Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-26 @ 1:49 PM
Study NCT ID:
NCT06239467
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'C000705452', 'term': 'tucatinib'}, {'id': 'C000589651', 'term': 'ribociclib'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify maximum tolerated dose (MTD) of OKI-219 in monotherapy', 'timeFrame': 'Cycle 1 (First 28 days on treatment)', 'description': 'Frequency of participants experiencing dose-limiting toxicities during the first 28-day cycle'}, {'measure': 'Assess safety of OKI-219 as monotherapy or in combination with other anti-cancer therapies: incidence of SAEs', 'timeFrame': 'Through 30 days after last dose, an average of 1 year', 'description': 'Number and type of SAEs experienced by participants during treatment and follow-up'}, {'measure': 'Assess safety of OKI-219 as monotherapy or in combination with other anti-cancer therapies: incidence of Grade 2 or greater treatment emergent adverse events', 'timeFrame': 'Through 30 days after last dose, an average of 1 year', 'description': 'Number of treatment-emergent adverse events (TEAEs) equal or greater than Grade 2 experienced during treatment and follow-up'}, {'measure': 'Assess rate of dose modifications during treatment with OKI-219 as monotherapy or in combination with other anti-cancer therapies', 'timeFrame': 'Through last study dose, an average of 1 year', 'description': 'rate of dose modifications'}], 'secondaryOutcomes': [{'measure': 'Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with other anti-cancer therapies: maximum plasma concentration (Cmax)', 'timeFrame': 'Through cycle 6 of treatment (up to 28 weeks)', 'description': 'PK of OKI-219: Cmax'}, {'measure': 'Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with other anti-cancer therapies: time of maximum plasma concentration (Tmax)', 'timeFrame': 'Through cycle 6 of treatment (up to 28 weeks)', 'description': 'PK of OKI-219: Tmax'}, {'measure': 'Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with other anti-cancer therapies: area under the plasma concentration-time curve (AUC)', 'timeFrame': 'Through cycle 6 of treatment (up to 28 weeks)', 'description': 'PK of OKI-219: AUC'}, {'measure': 'Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with other anti-cancer therapies: terminal elimination half-life time (t1/2)', 'timeFrame': 'Through cycle 6 of treatment (up to 28 weeks)', 'description': 'PK of OKI-219: t1/2'}, {'measure': 'To estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: objective response rate (ORR)', 'timeFrame': 'Up to approximately 36 months', 'description': 'ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)'}, {'measure': 'To estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: clinical benefit rate (CBR)', 'timeFrame': 'Up to approximately 36 months', 'description': 'CBR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)'}, {'measure': 'Dose optimization only: to estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: progression free survival (PFS)', 'timeFrame': 'Up to approximately 36 months', 'description': 'PFS per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)'}, {'measure': 'To assess the dose-response impact of OKI-219 as monotherapy and in combination with other anti-cancer therapies on PI3KαH1047R ctDNA levels', 'timeFrame': 'Through last study dose, an average of 1 year', 'description': 'Changes in PI3KαH1047R ctDNA on treatment and end of treatment (EOT) compared to baseline.'}, {'measure': 'To determine the impact of OKI-219 dosing as monotherapy and in combination with other anti-cancer therapies on blood glucose and insulin', 'timeFrame': 'Through last study dose, an average of 1 year', 'description': 'Changes in plasma glucose, serum insulin, serum c-peptide levels, and hemoglobin A1c (HbA1c) will be evaluated on treatment compared to baseline.'}, {'measure': 'To assess the PDx activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies', 'timeFrame': 'Through last study dose, an average of 1 year', 'description': 'PDx activity will be evaluated with serial tumor biopsy samples assessed for PI3K/AKT/mTOR downstream pathway changes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PI3K', 'Solid Tumor', 'Breast Cancer', 'OKI-219', 'trastuzumab', 'fulvestrant', 'H1047r', 'ribociclib', 'atirmociclib', 'tucatinib'], 'conditions': ['Advanced Cancer', 'Breast Cancer', 'Advanced Solid Tumors', 'PI3K Gene Mutation']}, 'descriptionModule': {'briefSummary': 'OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs. Phase 1a (Part A) will investigate escalating doses of OKI-219 monotherapy, and Phase 1b will investigate OKI-219 (at a tolerated dose determined in Part A) in combination with fulvestrant (Part B), trastuzumab and tucatinib (Part C), atirmociclib (Part D), and ribociclib and fulvestrant (Part E). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Participants with advanced solid tumors with documented evidence of a PI3KαH1047R mutation in tumor tissue and/or blood (ie, ctDNA).\n* Eastern Cooperative Oncology Group (ECOG) Performance status score of to 1.\n* Life expectancy \\> 12 weeks for Part A and \\> 6 months for Parts B, C, D, and E in the opinion of the Investigator.\n* Adequate organ and bone marrow function\n* Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.\n* At least 1 measurable lesion based on RECIST version 1.1.\n\nAdditional Cohort-specific key inclusion criteria:\n\nPart A\n\n* Participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer, must have received at least 1 prior line of hormonal therapy and at least 1 prior line of CDK4/6-inhibitor in the advanced or metastatic setting.\n* Participants with HER2+ locally advanced, unresectable or metastatic breast cancer, must have received prior taxane, trastuzumab, pertuzumab, and tucatinib. Prior trastuzumab deruxtecan is allowed but not required.\n* Participants with HER2-low breast cancer must have received prior trastuzumab deruxtecan.\n* Participants with colorectal cancer must have KRAS wild-type disease.\n\nPart B\n\n* Participants with locally advanced, unresectable or metastatic HR+/HER2- breast cancer must have received at least 1 prior line of hormonal therapy in the advanced or metastatic setting and at least 1 prior CDK4/6-inhibitor.\n* Participants with HER2-low breast cancer should have received prior trastuzumab deruxtecan\n\nPart C ● Participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer must have received prior taxane, trastuzumab, and pertuzumab unless unavailable in the region or contraindicated. Prior trastuzumab deruxtecan is allowed but not required.\n\nPart D\n\n● Participants must have HR+/HER2- locally advanced, unresectable or metastatic breast cancer\n\nPart E ● Participants must have HR+/HER2- locally advanced, unresectable or metastatic breast cancer.\n\nKey Exclusion Criteria:\n\n* Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, of the start of treatment\n* Participants with a known KRAS mutation.\n* Participants with a known deleterious mutation in phosphatase and tensin homolog (PTEN) or negative for PTEN protein expression by IHC.\n* Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of study drug.\n* Known active central nervous system metastasis, including leptomeningeal disease.\n* Uncontrolled Type 1 or Type 2 diabetes as defined by HbA1C ≥ 8%.\n* Concomitant active malignancy or previous malignancy within 2 years of the time of enrollment.\n* Impaired cardiovascular function or clinically significant cardiovascular disease,\n* History of symptomatic drug-induced pneumonitis.\n* Participants with active HIV, Hepatitis B, and Hepatitis C viral infections\n\nAdditional Cohort-specific key exclusion criteria:\n\nPart C:\n\n* Grade 2 or higher diarrhea at study entry.\n* History of chronic liver disease.\n\nPart E:\n\n● History of interstitial lung disease.'}, 'identificationModule': {'nctId': 'NCT06239467', 'acronym': 'PIKture-01', 'briefTitle': 'First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'OnKure, Inc.'}, 'officialTitle': 'PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and as Part of Combination Therapy in Participants With Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'OKI-219-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1a: Part A Dose Escalation', 'description': 'OKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part B Dose Escalation', 'description': 'OKI-219 + Fulvestrant Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219', 'Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part B Dose Optimization', 'description': 'OKI-219 + Fulvestrant Dose Optimization in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219', 'Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part C Dose Escalation', 'description': 'OKI-219 + Tucatinib + Trastuzumab Dose Escalation in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219', 'Drug: Trastuzumab', 'Drug: Tucatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part C Dose Expansion', 'description': 'OKI-219 + Tucatinib + Trastuzumab Dose Expansion in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219', 'Drug: Trastuzumab', 'Drug: Tucatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part D Dose Escalation', 'description': 'OKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219', 'Drug: Fulvestrant', 'Drug: Atirmociclib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part D Dose Expansion', 'description': 'OKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219', 'Drug: Fulvestrant', 'Drug: Atirmociclib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part E Dose Escalation', 'description': 'OKI-219 + Fulvestrant + Ribociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219', 'Drug: Fulvestrant', 'Drug: Ribociclib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part E Dose Expansion', 'description': 'OKI-219 + Fulvestrant + Ribociclib Dose Expansion in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation', 'interventionNames': ['Drug: OKI-219', 'Drug: Fulvestrant', 'Drug: Ribociclib']}], 'interventions': [{'name': 'OKI-219', 'type': 'DRUG', 'description': 'Oral twice daily', 'armGroupLabels': ['Phase 1a: Part A Dose Escalation', 'Phase 1b: Part B Dose Escalation', 'Phase 1b: Part B Dose Optimization', 'Phase 1b: Part C Dose Escalation', 'Phase 1b: Part C Dose Expansion', 'Phase 1b: Part D Dose Escalation', 'Phase 1b: Part D Dose Expansion', 'Phase 1b: Part E Dose Escalation', 'Phase 1b: Part E Dose Expansion']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'Intramuscular injection', 'armGroupLabels': ['Phase 1b: Part B Dose Escalation', 'Phase 1b: Part B Dose Optimization', 'Phase 1b: Part D Dose Escalation', 'Phase 1b: Part D Dose Expansion', 'Phase 1b: Part E Dose Escalation', 'Phase 1b: Part E Dose Expansion']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'Intravenous (IV)', 'armGroupLabels': ['Phase 1b: Part C Dose Escalation', 'Phase 1b: Part C Dose Expansion']}, {'name': 'Tucatinib', 'type': 'DRUG', 'description': 'Oral twice daily', 'armGroupLabels': ['Phase 1b: Part C Dose Escalation', 'Phase 1b: Part C Dose Expansion']}, {'name': 'Atirmociclib', 'type': 'DRUG', 'description': 'Oral twice daily', 'armGroupLabels': ['Phase 1b: Part D Dose Escalation', 'Phase 1b: Part D Dose Expansion']}, {'name': 'Ribociclib', 'type': 'DRUG', 'description': 'Oral once daily continuous for 21-days followed by 7 days off', 'armGroupLabels': ['Phase 1b: Part E Dose Escalation', 'Phase 1b: Part E Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dante Pasiliao', 'role': 'CONTACT', 'email': 'dpasiliao@ccare.com'}], 'facility': 'California Cancer Associates for Research and Excellence', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Fernandez', 'role': 'CONTACT', 'email': 'jtfernandez@health.ucsd.edu'}], 'facility': 'University of California San Diego UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Doris Quintanilla', 'role': 'CONTACT', 'email': 'dquintanilla@mednet.ucla.edu'}], 'facility': 'UCLA Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abigail Lazo', 'role': 'CONTACT', 'email': 'abigail.lazo@hoag.org'}], 'facility': 'Hoag - Huntington Beach', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leah Adams', 'role': 'CONTACT', 'email': 'Leah.Adams@cuanschutz.edu'}], 'facility': 'Regents of the University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Ellis', 'role': 'CONTACT', 'email': 'Jessica.Ellis@SarahCannon.com'}], 'facility': 'Sarah Cannon Research Institute at HealthONE', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Petersen', 'role': 'CONTACT', 'email': 'jpetersen3@mgb.org'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Karmanos Cancer Insitute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Hutchings', 'role': 'CONTACT', 'email': 'elizabeth.hutchings@usoncology.com'}], 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pushpa Talanki', 'role': 'CONTACT', 'email': 'Pushpa.talanki@stonybrookmedicine.edu'}], 'facility': 'Stony Brook University', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gretchen Johnston', 'role': 'CONTACT', 'email': 'gretchen.johnston@scri.com'}], 'facility': 'SCRI Oncology Partners - Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blake Patterson', 'role': 'CONTACT', 'email': 'bpatterson@nextoncology.com'}], 'facility': 'NEXT Oncology Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaysey Hermens', 'role': 'CONTACT', 'email': 'khermens@fredhutch.org'}], 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '1070', 'city': 'Anderlecht', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pierre-Andre Bouchonville', 'role': 'CONTACT', 'email': 'p-a.bouchonville@hubruxelles.be'}], 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Inge Van Uffel', 'role': 'CONTACT', 'email': 'inge.vanuffel@uzleuven.be'}], 'facility': 'UZ Leuven - Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2610', 'city': 'Wilrijk', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Caroline Merckx', 'role': 'CONTACT', 'email': 'caroline.merckx@zas.be'}], 'facility': 'GZA Hopsitals Campus Sint-Augustinus', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Peggy Philippe', 'role': 'CONTACT', 'email': 'pphilippe@cgfl.fr'}], 'facility': 'Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL)', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59020', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amelie Decourcelle', 'role': 'CONTACT', 'email': 'a-decourcelle@o-lambret.fr'}], 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amelie Vey', 'role': 'CONTACT', 'email': 'amelie.vey@lyon.unicancer.fr'}], 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '06189', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jennifer Oudard', 'role': 'CONTACT', 'email': 'jennifer.oudard@nice.unicancer.fr'}], 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christine Gerentet', 'role': 'CONTACT', 'email': 'christine.gerentet@chu-lyon.fr'}], 'facility': 'Hopital Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Djedjiga Oudni', 'role': 'CONTACT', 'email': 'djedjiga.oudni@gustaveroussy.fr'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Jessica Filoni', 'role': 'CONTACT', 'email': 'filoni.jessica@hsr.it'}], 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20900', 'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Edoardo Mauri', 'role': 'CONTACT', 'email': 'edoardo.mauri@irccs-sangerardo.it'}], 'facility': 'Ospedale San Gerardo-ASST Monza', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '20089', 'city': 'Rozzano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Camorani', 'role': 'CONTACT', 'email': 'andrea.camorani@humanitas.it'}], 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '21565', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyerim Choi', 'role': 'CONTACT', 'email': 'jasmin993075@naver.com'}], 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yuri Ko', 'role': 'CONTACT', 'email': 'gosima0225@snu.ac.kr'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jieun Kim', 'role': 'CONTACT', 'email': 'jekim1@yuhs.ac'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Mi Yeon Park', 'role': 'CONTACT', 'email': 'miyeonpark@amc.seoul.kr'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Inkyung Jung', 'role': 'CONTACT', 'email': 'ik.jung@samsung.com'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08023', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Abigail Huerta', 'role': 'CONTACT', 'email': 'ahuerta@nextoncology.eu'}], 'facility': 'NEXT Oncology Phase I Unit / IOB- Hospital Quironsalud Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pilar Chaparro', 'role': 'CONTACT', 'email': 'Pilar.Chaparro@iobmadrid.com'}], 'facility': 'Hospital Beata Maria Ana', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raquel Rodriguez', 'role': 'CONTACT', 'email': 'unidafase1.imas12@h12o.es'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Irene Valderrama', 'role': 'CONTACT', 'email': 'Irene.Valderrama@startmadrid.com'}], 'facility': 'START - Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'OnKure, Inc.', 'role': 'CONTACT', 'email': 'info@onkure.com', 'phone': '720-307-2892'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OnKure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}