Status:
RECRUITING
Study of RP-6306 Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
Lead Sponsor:
Repare Therapeutics
Collaborating Sponsors:
Debiopharm International SA
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to assess the safety and tolerability of RP-6306 alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid t...
Detailed Description
Phase 1/1b, multi-center, open-label, dose-escalation study to: * Evaluate the safety profile and MTD of RP-6306 alone and in combination with RP-3500 or in combination with Debio 0123 when administe...
Eligibility Criteria
Inclusion
- Male or female and ≥12 years-of-age at the time of informed consent.
- Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \>16 years of age.
- Locally advanced or metastatic resistant or refractory solid tumors.
- Patients \<18 years of age must weigh at least 40 kg.
- Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
- Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.
- CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH
- FBXW7 deleterious mutations identified by either a tumor or plasma NGS test
- PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test
- Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible
- Ability to swallow and retain oral medications.
- Acceptable hematologic and organ function at screening.
- Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
- Resolution of all toxicities of prior therapy or surgical procedures.
- Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
Exclusion
- Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half-lives, whichever is shorter, prior to first dose of study drug.
- 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.
- Patients who are pregnant or breastfeeding.
- Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
- Major surgery within 4 weeks prior to first dose of RP-6306.
- Uncontrolled, symptomatic brain metastases.
- Uncontrolled hypertension.
- Certain prior anti-cancer therapy
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT04855656
Start Date
April 30 2021
End Date
December 31 2026
Last Update
August 6 2025
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
#1016, Mayo Clinic
Phoenix, Arizona, United States, 85054
2
# 1019, UCLA, Westwood Cancer Center
Los Angeles, California, United States, 90095
3
#1025, University of California San Francisco
San Francisco, California, United States, 94158
4
#1012, Yale
New Haven, Connecticut, United States, 06520