Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2026-01-02 @ 2:37 AM
Study NCT ID:
NCT04585750
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D005706', 'term': 'Gallbladder Neoplasms'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'During Phase 2 Monotherapy, 2000mg QD of PC14586 (INN: rezatapopt) will be assigned to all participants. Participants will be assigned to one of five cohorts: ovarian cancer, lung cancer, breast cancer, endometrial cancer, or other solid tumors. Enrollment ongoing.\n\nDuring Phase 1 Monotherapy (Dose Escalation), participants will be assigned a dose level using an accelerated titration design in the initial dose cohorts, followed by a modified toxicity probability interval (mTPI) design in subsequent dose cohorts. Enrollment closed.\n\nDuring Part 1 of the Ph 1b Combination Therapy, patients will be assigned a dose level using mTPI design. A recommended rezatapopt Phase 2 Dose (RP2D) when administered in combination with pembrolizumab will be selected at the end of Phase 1b Part 1, and the RP2D will be assigned to all participants in Part 2. Enrollment closed.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt', 'timeFrame': '40 months', 'description': 'Number of participants with treatment related adverse events'}, {'measure': 'Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D)', 'timeFrame': '30 months', 'description': 'RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data'}, {'measure': 'Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1)', 'timeFrame': 'The first 28 days of treatment (Cycle 1) per patient', 'description': 'Incidence of dose limiting toxicities (DLTs) during the first 28 days of treatment with rezatapopt'}, {'measure': 'Phase 1b Combination Therapy (Part 1: Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab', 'timeFrame': '18 months for treatment arm', 'description': 'Number of participants with treatment related adverse events'}, {'measure': 'Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the maximum tolerated dose (MTD) of rezatapopt when administered in combination with pembrolizumab', 'timeFrame': 'The first 28 days of combination treatment arm (starting on Day -7) per patient', 'description': 'Incidence of dose limiting toxicities (DLTs) during the first 28 days of treatment with rezatapopt'}, {'measure': 'Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D) of rezatapopt when administered in combination with pembrolizumab', 'timeFrame': '18 months', 'description': 'RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data'}, {'measure': 'Phase 1b Combination Therapy (Part 2: Dose Expansion): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab', 'timeFrame': '12 months for treatment arm', 'description': 'Number of participants with treatment related adverse events'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt', 'timeFrame': '34 months', 'description': 'Overall response rate in accordance with Response Evaluation Criteria (RECIST) v.1.1 as assessed by independent review across all cohorts'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt in ovarian cancer patients', 'timeFrame': '34 months', 'description': 'Overall response rate in accordance with Response Evaluation Criteria (RECIST) v.1.1 as assessed by independent review in the ovarian cancer cohort'}], 'secondaryOutcomes': [{'measure': 'Phase 1 Monotherapy: PK profile of rezatapopt - Peak concentration (Cmax)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1 Monotherapy: PK profile of rezatapopt - Time of peak concentration (Tmax)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve in one dosing interval (AUCtau)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1 Monotherapy: PK profile of rezatapopt - Trough observed concentrations (Ctrough/Ctau)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1 Monotherapy: Blood plasma assessment to describe the concentration of PC14586 and metabolites when rezatapopt is administered orally.', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Blood plasma concentration'}, {'measure': 'Phase 1 Monotherapy (Dose Escalation): Overall Response Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1', 'timeFrame': '41 months for study (end of Phase 1)', 'description': 'Evaluation of preliminary anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 1 Monotherapy (Dose Escalation): Time to Response per RECIST v1.1 or PCWG3 modified RECIST v1.1', 'timeFrame': '41 months for study (end of Phase 1)', 'description': 'Evaluation of preliminary anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 1 Monotherapy (Dose Escalation): Duration of Response per RECIST v1.1 or PCWG3 modified RECIST v1.1', 'timeFrame': '41 months for study (end of Phase 1)', 'description': 'Evaluation of preliminary anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 1 Monotherapy (Dose Escalation): Disease Control Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1', 'timeFrame': '41 months for study (end of Phase 1)', 'description': 'Evaluation of preliminary anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 1 Monotherapy (Dose Escalation): Progression Free Survival per RECIST v1.1 or PCWG3 modified RECIST v1.1', 'timeFrame': '41 months for study (end of Phase 1)', 'description': 'Evaluation of preliminary anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 1 Monotherapy (Dose Escalation): Overall Survival', 'timeFrame': '41 months for study (end of Phase 1)', 'description': 'Evaluation of preliminary anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Peak concentration (Cmax)', 'timeFrame': 'Approximately 12 months per patient (30 months for treatment arm)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Time of peak concentration (Tmax)', 'timeFrame': 'Approximately 12 months per patient (30 months for treatment arm)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)', 'timeFrame': 'Approximately 12 months per patient (30 months for treatment arm)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Area under the plasma concentration-time curve in one dosing interval (AUCtau)', 'timeFrame': 'Approximately 12 months per patient (30 months for treatment arm)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Trough observed concentrations (Ctrough/Ctau)', 'timeFrame': 'Approximately 12 months per patient (30 months for treatment arm)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 1b Combination Therapy: Blood plasma assessment to describe the concentration of rezatapopt and metabolites when rezatapopt is administered orally in combination with pembrolizumab.', 'timeFrame': 'Approximately 12 months per patient (30 months for treatment arm)', 'description': 'Blood plasma concentration'}, {'measure': 'Phase 1b Combination Therapy: Overall Response Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review', 'timeFrame': '30 months for study (end of Phase 1b)', 'description': 'Evaluation of anti-tumor activity of rezatapopt in combination with pembrolizumab'}, {'measure': 'Phase 1b Combination Therapy: Time to Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review', 'timeFrame': '30 months for study (end of Phase 1b)', 'description': 'Evaluation of anti-tumor activity of rezatapopt in combination with pembrolizumab'}, {'measure': 'Phase 1b Combination Therapy: Duration of Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review', 'timeFrame': '30 months for study (end of Phase 1b)', 'description': 'Evaluation of anti-tumor activity of rezatapopt in combination with pembrolizumab'}, {'measure': 'Phase 1b Combination Therapy: Disease Control Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review', 'timeFrame': '30 months for study (end of Phase 1b)', 'description': 'Evaluation of anti-tumor activity of rezatapopt in combination with pembrolizumab'}, {'measure': 'Phase 1b Combination Therapy: Overall Survival', 'timeFrame': '30 months for study (end of Phase 1b)', 'description': 'Evaluation of anti-tumor activity of rezatapopt in combination with pembrolizumab'}, {'measure': 'Phase 1b Combination Therapy: Determine the number and type of adverse events to characterize the safety of rezatapopt', 'timeFrame': '30 months for study (end of Phase 1b)', 'description': 'Number of participants with treatment related adverse events'}, {'measure': 'Phase 1b Combination Therapy: Progression Free Survival per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review', 'timeFrame': '30 months for study (end of Phase 1b)', 'description': 'Evaluation of anti-tumor activity of rezatapopt in combination with pembrolizumab'}, {'measure': 'Phase 2 Monotherapy: PK profile of rezatapopt - Time of peak concentration (Tmax)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 2 Monotherapy: PK profile of rezatapopt - Peak concentration (Cmax)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 2 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 2 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve in one dosing interval (AUCtau)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 2 Monotherapy: PK profile of rezatapopt - Trough observed concentrations (Ctrough/Ctau)', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt'}, {'measure': 'Phase 2 Monotherapy: Blood plasma assessment to describe the concentration of rezatapopt and metabolites when rezatapopt is administered orally.', 'timeFrame': 'Approximately 12 months per patient (75 months for Phase 1 and Phase 2)', 'description': 'Blood plasma concentration'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Determine the number and type of adverse events to characterize the safety of rezatapopt', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Number of participants with treatment related adverse events'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Overall Response Rate across all cohorts per RECIST v1.1 as assessed by Investigator', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Overall Response Rate in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Time to Response in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Time to Response across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Duration of Response in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Duration of Response across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Disease Control Rate in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Disease Control Rate across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Progression Free Survival in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Progression Free Survival across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Overall Survival in ovarian cancer cohort', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Overall Survival across all cohorts', 'timeFrame': '34 months for study (end of Phase 2)', 'description': 'Evaluation of anti-tumor activity of rezatapopt as a single agent'}, {'measure': 'Phase 2 Monotherapy (Dose Expansion): Quality of life assessment', 'timeFrame': 'Evaluated at every visit. 34 months for treatment arm (end of Phase 2)', 'description': 'Changes from baseline in quality of life as measured by a validated instrument, for participants 18 and older'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PC14586', 'p53', 'Y220C', 'Phase 1', 'Phase 1/2', 'PMV', 'PMV Pharma', 'p53 mutation', 'TP53', 'TP53 mutation', 'p53 mutant', 'p53 reactivator', 'pembrolizumab', 'Keytruda', 'combination', 'PD-1', 'PD-L1', 'anti-PD-1', 'Merck', 'MSD', 'IgG4', 'mAb', 'Phase 1b', 'NGS', 'Next Generation Sequencing', 'precision', 'Phase 2', 'Rezatapopt'], 'conditions': ['Advanced Solid Tumor', 'Advanced Malignant Neoplasm', 'Metastatic Cancer', 'Metastatic Solid Tumor', 'Lung Cancer', 'Ovarian Cancer', 'Endometrial Cancer', 'Prostate Cancer', 'Colorectal Cancer', 'Breast Cancer', 'Other Cancer', 'Locally Advanced', 'Head and Neck Cancer', 'Gall Bladder Cancer', 'Small Cell Lung Cancer', 'Small Cell Lung Cancer ( SCLC )', 'Small Cell Lung Carcinoma', 'NSCLC', 'NSCLC (Non-small Cell Lung Cancer)', 'SCLC', 'Non-Small Cell Lung Carcinoma', 'Triple Negative Breast Cancer', 'TNBC', 'HER2+ Breast Cancer', 'Non-Small Cell Lung Cancer', 'ER/PR Positive Breast Cancer', 'HER2- Breast Cancer', 'HER2-positive Breast Cancer', 'HER2-negative Breast Cancer', 'ER/PR(+), Her2(-) Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40932470', 'type': 'DERIVED', 'citation': 'Schram AM, Fellous M, LeDuke K, Schmid A, Dumbrava EE. PYNNACLE phase II clinical trial protocol: rezatapopt (PC14586) monotherapy in advanced or metastatic solid tumors with a TP53 Y220C mutation. Future Oncol. 2025 Oct;21(24):3159-3166. doi: 10.1080/14796694.2025.2557176. Epub 2025 Sep 11.'}, {'pmid': '40543428', 'type': 'DERIVED', 'citation': 'Papavassiliou KA, Vassiliou AG, Papavassiliou AG. Rezatapopt: A promising small-molecule "refolder" specific for TP53Y220C mutant tumors. Neoplasia. 2025 Sep;67:101201. doi: 10.1016/j.neo.2025.101201. Epub 2025 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.', 'detailedDescription': 'Rezatapopt is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation.\n\nThe primary objective of Phase 2 Monotherapy is to evaluate the efficacy of rezatapopt at the Recommended Phase 2 Dose (RP2D) including the Overall Response Rate (ORR) in the Ovarian Cancer Cohort and the ORR across all cohorts as determined by blinded independent central review. Secondary objectives of Phase 2 are to characterize the safety, pharmacokinetic (PK) properties, quality of life, and other efficacy measures of PC14586 rezatapopt at the RP2D. Enrollment is open for the Phase 2 Monotherapy portion of the study.\n\nThe primary objective of Phase 1 Monotherapy is to establish the maximum tolerated dose (MTD) and RP2D of rezatapopt. Secondary objectives are to characterize the PK properties, safety and tolerability, and to assess preliminary efficacy including ORR. Enrollment into Phase 1 Monotherapy is complete.\n\nThe primary objective of Phase 1b Combination Therapy is to establish the MTD/RP2D of rezatapopt when administered in combination with pembrolizumab. Secondary objectives of Phase 1b Combination Therapy are to characterize PK, safety and tolerability, and to assess preliminary efficacy of rezatapopt when administered in combination with pembrolizumab, including ORR. Enrollment into Phase 1b Combination Therapy is complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1/PD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors/inducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis / interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt'}, 'identificationModule': {'nctId': 'NCT04585750', 'briefTitle': 'The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PMV Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)', 'orgStudyIdInfo': {'id': 'PMV-586-101'}, 'secondaryIdInfos': [{'id': 'KEYNOTE-D79', 'type': 'REGISTRY', 'domain': 'Merck, Sharp & Dohme, LLC'}, {'id': 'MK-3475-D79', 'type': 'REGISTRY', 'domain': 'Merck, Sharp & Dohme, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 Monotherapy Dose Escalation', 'description': 'Multiple dose levels of daily oral rezatapopt will be evaluated in an escalating manner, to determine the maximum tolerated dose and to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of rezatapopt to recommend a Phase 2 dose (RP2D).', 'interventionNames': ['Drug: rezatapopt']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Combination Therapy Dose Escalation, Part 1', 'description': 'Multiple dose levels of daily oral rezatapopt in combination with a stable dose of pembrolizumab (200 mg IV q3 weeks) will be evaluated in an escalating manner, to determine the maximum tolerated dose and to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of PC14586 to recommend a Phase 2 dose (RP2D) of rezatapopt when administered in combination with pembrolizumab.', 'interventionNames': ['Drug: rezatapopt', 'Drug: pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patients', 'description': 'Additional (expansion of) participants will enroll at the RP2D of daily oral PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab (200 mg IV q3 weeks) for continued evaluation. Participants will have advanced solid tumors harboring a p53 Y220C mutation and are PD(L)-1 naive patients.', 'interventionNames': ['Drug: rezatapopt', 'Drug: pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patients', 'description': 'Additional (expansion of) participants will enroll at the RP2D of daily oral rezatapopt when administered in combination with pembrolizumab (200 mg IV q3 weeks) for continued evaluation. Participants will have advanced solid tumors harboring a p53 Y220C mutation and are PD(L)-1 relapsed/refractory patients.', 'interventionNames': ['Drug: rezatapopt', 'Drug: pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Monotherapy Dose Expansion, Ovarian Cancer Cohort', 'description': 'Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Ovarian Cancer Cohort participants will have locally advanced or metastatic ovarian cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.', 'interventionNames': ['Drug: rezatapopt']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Monotherapy Dose Expansion, Lung Cancer Cohort', 'description': 'Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Lung Cancer Cohort participants will have locally advanced or metastatic lung cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.', 'interventionNames': ['Drug: rezatapopt']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Monotherapy Dose Expansion, Breast Cancer Cohort', 'description': 'Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Breast Cancer Cohort participants will have locally advanced or metastatic breast cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.', 'interventionNames': ['Drug: rezatapopt']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Monotherapy Dose Expansion, Endometrial Cancer Cohort', 'description': 'Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Endometrial Cancer Cohort participants will have locally advanced or metastatic endometrial cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.', 'interventionNames': ['Drug: rezatapopt']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Monotherapy Dose Expansion, Other Solid Tumors Cohort', 'description': 'Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Other Solid Tumors Cohort participants will have locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.', 'interventionNames': ['Drug: rezatapopt']}], 'interventions': [{'name': 'rezatapopt', 'type': 'DRUG', 'otherNames': ['PC14586'], 'description': 'First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.', 'armGroupLabels': ['Phase 1 Monotherapy Dose Escalation', 'Phase 1b Combination Therapy Dose Escalation, Part 1', 'Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patients', 'Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patients', 'Phase 2 Monotherapy Dose Expansion, Breast Cancer Cohort', 'Phase 2 Monotherapy Dose Expansion, Endometrial Cancer Cohort', 'Phase 2 Monotherapy Dose Expansion, Lung Cancer Cohort', 'Phase 2 Monotherapy Dose Expansion, Other Solid Tumors Cohort', 'Phase 2 Monotherapy Dose Expansion, Ovarian Cancer Cohort']}, {'name': 'pembrolizumab', 'type': 'DRUG', 'otherNames': ['KEYTRUDA®', 'MK-3475', 'KEYNOTE-D79', 'MK-3475-D79'], 'description': 'Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.', 'armGroupLabels': ['Phase 1b Combination Therapy Dose Escalation, Part 1', 'Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patients', 'Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zhaohui Arter, MD', 'role': 'CONTACT'}], 'facility': 'University of California Irvine Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gottfried Konecny, MD', 'role': 'CONTACT'}], 'facility': 'UCLA Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony El-Khoueiry, MD', 'role': 'CONTACT'}], 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allen Cohn, MD', 'role': 'CONTACT'}], 'facility': 'Rocky Mountain Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patricia LoRusso, MD', 'role': 'CONTACT'}], 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamal Misleh, MD', 'role': 'CONTACT'}], 'facility': 'Medical Oncology Hematology Consultants', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gilberto de Lima Lopes Jr., MD', 'role': 'CONTACT'}], 'facility': 'University of Miami - Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Guru Sonpavde, MD', 'role': 'CONTACT'}], 'facility': 'Advent Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33980', 'city': 'Port Charlotte', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ivor Percent, MD', 'role': 'CONTACT'}], 'facility': 'Florida Cancer Specialists South', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Devalingam Mahalingam, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aparna Parikh, MD', 'role': 'CONTACT'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Geoffrey Shapiro, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dipesh Uprety, MD', 'role': 'CONTACT'}], 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alison Schram, MD', 'role': 'CONTACT'}], 'facility': 'Memorial Sloan Kettering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Niharika Mettu, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dale Shepard, MD', 'role': 'CONTACT'}], 'facility': 'The Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debra Richardson, MD', 'role': 'CONTACT'}], 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shivaani Kummar, MD', 'role': 'CONTACT'}], 'facility': 'Oregon Health & Science University (OHSU)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lainie Martin, MD', 'role': 'CONTACT'}], 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Taylor, MD, PhD', 'role': 'CONTACT'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ikechukwu Akunyili, MD', 'role': 'CONTACT'}], 'facility': 'WellSpan York Cancer Center', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Kaczmar, MD', 'role': 'CONTACT'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Johnson, MD', 'role': 'CONTACT'}], 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Tolcher, MD', 'role': 'CONTACT'}], 'facility': 'New Experimental Therapeutics - NEXT Oncology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Miller, MD', 'role': 'CONTACT'}], 'facility': 'UTSW - Moody Outpatient Center - Parkland Health', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Miller, MD', 'role': 'CONTACT'}], 'facility': 'UT Southwest Simmons Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ecaterina Dumbrava, MD', 'role': 'CONTACT'}], 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Tolcher, MD', 'role': 'CONTACT'}], 'facility': 'New Experimental Therapeutics of San Antonio - NEXT Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Spira, MD', 'role': 'CONTACT'}], 'facility': 'Virginia Cancer Specialists', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Coveler, MD', 'role': 'CONTACT'}], 'facility': 'University of Washington, Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nataliya Uboha, MD, PhD', 'role': 'CONTACT'}], 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'Camperdown', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Peter Grimison, MD', 'role': 'CONTACT'}], 'facility': "Chris O'Brien Lifehouse Hospital", 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'city': 'South Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Catherine Shannon, MD', 'role': 'CONTACT'}], 'facility': 'Mater Cancer Care Centre', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'city': 'Bedford Park', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Shwagi Sukumaran, MD', 'role': 'CONTACT'}], 'facility': 'Flinders Medical Center', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Amy Body, MD', 'role': 'CONTACT'}], 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Michael Millward, MD', 'role': 'CONTACT'}], 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Strasbourg', 'state': 'Bas-Rhin', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lauriane Eberst, MD', 'role': 'CONTACT'}], 'facility': 'ICANS - Institut de cancérologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Bordeaux', 'state': 'Gironde', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine Italiano, MD', 'role': 'CONTACT'}], 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Toulouse', 'state': 'Haute-Garonne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carlos-Alberto Gomez-Roca, MD', 'role': 'CONTACT'}], 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Saint-Herblain', 'state': 'Loire-Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Sebastien Frenel, MD', 'role': 'CONTACT'}], 'facility': "EDOG Institut de Cancerologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Clermont-Ferrand', 'state': 'Puy-de-Dôme', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Durando, MD', 'role': 'CONTACT'}], 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Villejuif', 'state': 'Val-de-Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yohann Loriot, MD', 'role': 'CONTACT'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle Ray-Coquard, MD', 'role': 'CONTACT'}], 'facility': 'Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '30900', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric Fiteni, MD, PhD', 'role': 'CONTACT'}], 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '54519', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélien Lambert, MD', 'role': 'CONTACT'}], 'facility': 'Institute Cancer De Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Haag, MD', 'role': 'CONTACT'}], 'facility': 'Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Augsburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rainer Claus, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dirk Arnold, MD', 'role': 'CONTACT'}], 'facility': 'Asklepios Klinik Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Sebastian, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcel Wiesweg, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Scambia, MD', 'role': 'CONTACT'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenza Landi, MD', 'role': 'CONTACT'}], 'facility': 'Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Siena, MD', 'role': 'CONTACT'}], 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Di Nicola, MD', 'role': 'CONTACT'}], 'facility': 'Fondazione IRCCS Istituto Nazionale Dei Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Curigliano, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Europeo Di Oncologia', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Rozzano', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Armando Santoro, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Candiolo', 'state': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Lazzari, MD', 'role': 'CONTACT'}], 'facility': "Fondazione del Piemonte per l'Oncologia (IRCCS)", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenica Lorusso, MD', 'role': 'CONTACT'}], 'facility': 'Humanitas San Pio X', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Passarelli, MD', 'role': 'CONTACT'}], 'facility': 'IRCCS - 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