Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05159518
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of PRT2527 in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicities (DLT) of PRT2527', 'timeFrame': 'Baseline through Day 21', 'description': 'Dose limiting toxicities will be evaluated over the 21-day observation period'}, {'measure': 'Maximally tolerated dose (MTD) of PRT2527', 'timeFrame': 'Baseline through approximately 1 year', 'description': 'The MTD will be established for further investigation in participants with advanced solid tumors'}, {'measure': 'Recommended phase 2 dose (RP2D) and schedule of PRT2527', 'timeFrame': 'Baseline through approximately 1 year', 'description': 'The RP2D will be established for further investigation in participants with advanced solid tumors'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of PRT2527: AEs, SAEs, CTCAE assessments', 'timeFrame': 'Baseline through approximately 2 years', 'description': 'Safety and tolerability will be assessed by recording adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE)'}, {'measure': 'Pharmacokinetic profile of PRT2527: maximum observed plasma concentration', 'timeFrame': 'Baseline through approximately 1 year', 'description': 'PRT2527 pharmacokinetics will be calculated including the maximum observed plasma concentration'}, {'measure': 'Anti-tumor activity of PRT2527: measurement of objective responses', 'timeFrame': 'Baseline through approximately 2 years', 'description': 'Anti-tumor activity of PRT2527 based on the measurement of objective responses to PRT2527 according to the disease-specific response criteria for patients with advanced solid tumors'}, {'measure': 'Duration of response to PRT2527: Objective responses', 'timeFrame': 'Baseline through approximately 2 years', 'description': 'Duration of response will be calculated for all patients eligible for response determination from the time that a response is first observed until progression or death, whichever occurs first'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Castrate Resistant Prostate Cancer', 'CDK9 Inhibitor', 'CRPC', 'Cyclin-dependent Kinase 9', 'Hormone Receptor Positive HER2 Negative Breast Cancer', 'HR+/HER2- Breast Cancer', 'Non-small Cell Lung Cancer', 'NSCLC', 'Prostate Cancer', 'PRT2527', 'Refractory Solid Tumors', 'Relapsed Solid Tumors', 'Sarcoma'], 'conditions': ['Sarcoma', 'Castrate Resistant Prostate Cancer', 'Hormone Receptor Positive HER2 Negative Breast Cancer', 'Non-small Cell Lung Cancer', 'Solid Tumors With Known MYC Amplification']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors. The purpose of this study is to define the dosing schedule, and maximally tolerated dose to be used in subsequent development of PRT2527.', 'detailedDescription': 'This is a multicenter, open-label, dose-escalation and confirmation Phase 1 study of PRT2527, a CDK9 inhibitor, evaluating participants with selected advanced/metastatic sarcomas displaying a documented gene fusion, castrate resistant prostate cancer, hormone receptor positive HER2-negative breast cancer, advanced/metastatic non-small cell lung cancer, and solid tumors displaying MYC amplification. The study plan expects to evaluate approximately six dose levels of approximately 1-6 participants per dose level; however additional and/or intermediate dose levels may be explored. Taking into account pharmacokinetic and pharmacodynamic data from the preceding dose levels, the dose may be escalated until a dose limiting toxicity is identified. The total sample size will be approximately 30 patients for MTD and RP2D determination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tumor types under study\n\n 1. Selected sarcomas with a documented gene fusion\n 2. Castrate resistant prostate cancer (CRPC)\n 3. Hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer\n 4. Non-small cell lung cancer (NSCLC)\n 5. MYC amplified solid tumors\n* Must have measurable disease per RECIST 1.1; participants with CRPC or sarcoma may have nonmeasurable but evaluable disease\n* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1\n* Adequate organ function\n* Must provide tumor tissue sample to the central laboratory for biomarker analysis\n* Participants must have recovered from the effects of prior cancer-related therapy, radiotherapy, or surgery to ≤ Grade 1\n\nExclusion Criteria:\n\n* Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression\n* have a corrected QT interval \\>480 msec from prior or baseline\n* have impaired cardiac function or clinically significant cardiac disease\n* Treatment with strong inhibitors or inducers of CYP3A4\n* Prior exposure to a CDK9 inhibitor\n* History of another malignancy except for:\n\n 1. Curatively treated malignancy with no known active disease\n 2. Curatively treated non-melanoma skin cancer without evidence of disease\n 3. Curatively treated carcinoma in situ without evidence of disease\n* have undergone major surgery within 2 weeks prior to Week 1 Day 1\n* have had chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 28 days (whichever is shorter) prior to administration of the first dose of study drug on Week 1 Day 1.'}, 'identificationModule': {'nctId': 'NCT05159518', 'briefTitle': 'A Study of PRT2527 in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prelude Therapeutics'}, 'officialTitle': 'A Phase 1, Open-Label, Multicenter, Dose Escalation and Confirmation Study of PRT2527 in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'PRT2527-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRT2527', 'description': 'PRT2527 will be administered by intravenous infusion', 'interventionNames': ['Drug: PRT2527']}], 'interventions': [{'name': 'PRT2527', 'type': 'DRUG', 'description': 'PRT2527 will be administered by intravenous infusion', 'armGroupLabels': ['PRT2527']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute at HealthONE', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Drug Services, AdventHealth Celebration', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University, Sidney Kimmel Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Cancer Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'NEXT Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prelude Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}