Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT06560632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2024-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'C531550', 'term': 'olaparib'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of RP-3467 alone and in combination with olaparib', 'timeFrame': '20 months', 'description': 'Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed per NCI CTCAE v5.0 criteria'}, {'measure': 'To define a preliminary recommended Phase 2 dose (RP2D) of RP-3467 in combination with olaparib', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'To assess PK parameters of RP-3467 alone or in combination with olaparib with calculation of maximum observed plasma concentration (Cmax)', 'timeFrame': '19 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label Phase 1 trial to investigate the safety, PK, and pharmacodynamics of the Polθ inhibitor RP-3467 alone or in combination with the poly-ADP ribose polymerase inhibitor (PARPi) olaparib in adults with molecularly selected advanced solid tumors.', 'detailedDescription': 'This is a first-in-human Phase 1, multi-center, open-label, dose-escalation study to:\n\n* Evaluate the safety profile of RP-3467 when administered orally alone and in combination with olaparib and to define the MTD or MAD for RP-3467 monotherapy and the RP2D for the combination\n* Characterize the PK profile of RP-3467 alone and in combination with olaparib'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants ≥18 years of age at the time of signing the informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participant must have one of the following that has progressed or was non-responsive to prior systemic therapy and for which no standard or available known therapeutic option exists:\n\n 1. locally advanced or metastatic epithelial ovarian cancer (including fallopian tube or primary peritoneal), or\n 2. metastatic breast cancer, or\n 3. metastatic castration-resistant prostate cancer (mCRPC), or\n 4. pancreatic adenocarcinoma\n* Measurable disease per RECIST v1.1 (exceptions for participants with non-measurable but evaluable disease \\[per RECIST and or PSA/CA-125\\])\n* Next generation sequencing (NGS) report demonstrating eligible tumor biomarker\n* Provision of archival tumor tissue, or if adequate archival tumor tissue is not available, provision of a fresh biopsy if there is a lesion that can be safely biopsied\n* Acceptable organ function at Screening\n* Acceptable hematologic function at Screening\n* Life expectancy ≥12 weeks after the start of the treatment according to the Investigator's judgment\n\nExclusion Criteria:\n\n* History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.\n* Uncontrolled, symptomatic brain metastases.\n* Presence of other known active invasive cancers\n* History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis\n* Prior therapy with a Polθ inhibitor other than RP-3467"}, 'identificationModule': {'nctId': 'NCT06560632', 'acronym': 'POLAR', 'briefTitle': 'Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Repare Therapeutics'}, 'officialTitle': 'Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors (POLAR Trial)', 'orgStudyIdInfo': {'id': 'RP-3467-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: RP-3467 monotherapy', 'description': 'Eligible participants will be treated with escalating doses of RP-3467 monotherapy', 'interventionNames': ['Drug: RP-3467 at assigned dose and schedule']}, {'type': 'EXPERIMENTAL', 'label': 'Arm2: RP-3467 + Olaparib combination', 'description': 'Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib', 'interventionNames': ['Drug: RP-3467 at assigned dose and schedule', 'Drug: Olaparib 200-300 mg BID, daily']}], 'interventions': [{'name': 'RP-3467 at assigned dose and schedule', 'type': 'DRUG', 'description': 'Eligible participants will be treated with escalating doses of RP-3467 monotherapy', 'armGroupLabels': ['Arm 1: RP-3467 monotherapy', 'Arm2: RP-3467 + Olaparib combination']}, {'name': 'Olaparib 200-300 mg BID, daily', 'type': 'DRUG', 'otherNames': ['RP-3467 at assigned dose and schedule', 'Lynparza'], 'description': 'Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib', 'armGroupLabels': ['Arm2: RP-3467 + Olaparib combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': '# 1025, The University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': '# 1011, The Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': '# 1008, Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': '# 1004, Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '# 1001, The University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Repare Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}