CLINICAL TRIALS OVERVIEW
We have a robust collection of clinical trials that are actively recruiting to evaluate our drug candidates.
Clinical trials involve the administration of an investigational new drug to human subjects under the supervision of qualified investigators in accordance with good clinical practice (GCP) requirements. A separate submission to the existing investigational new drug (IND) must be made for each successive clinical trial conducted during product development, as well as amendments to previously submitted clinical trials.
Further, an independent review board (IRB) for each institution participating in the clinical trial must review and approve the plan for any clinical trial, its informed consent form, and other communications to study subjects before the clinical trial commences at that site. The IRB must continue to oversee the clinical trial while it is being conducted, including any changes to the study plans.
Repare Therapeutics is recruiting patients in the U.S. and other countries for the following active clinical trials. Please follow the links below for more information for each study and site location.
Clinical Trials
| Clinical Trial | Overview |
|---|---|
|
TRESR
Camonsertib (RP-3500-01)
Phase 1/2: Actively Recruiting
|
Overview:
This first-in-human, Phase 1/2a, multi-center, open-label, dose-escalation, dose-expansion study is evaluating camonsertib in patients with advanced recurrent tumors of different histologies with ATM loss-of-function or one of 16 STEP2-identified genomic alterations. The primary purpose of this study is to define the maximum tolerated dose (MTD) and determine a recommended Phase 2 dose (RP2D) and schedule of orally-administered camonsertib alone or in combination with talazoparib, a PARP inhibitor, or gemcitabine in patients with advanced solid tumors with ATR inhibitor-sensitizing mutations. This study will also evaluate the safety and tolerability of camonsertib alone or in combination with talazoparib or gemcitabine, examine both the pharmacokinetics (PK) and pharmacodynamics (PD) and investigate its anti-tumor activity in solid tumors. An evaluation of safety and tolerability in children over 4 years old will be initiated. Visit ClinicalTrials.gov (NCT04497116) for more information about this trial. |
|
ATTACC
Camonsertib (RP-3500-03) + PARP (niraparib/olaparib) Combo
Phase 1/2: Actively Recruiting
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Overview:
This first-in-human, Phase 1b/2, multi-center, open-label, dose-escalation, dose-expansion study is evaluating camonsertib in patients with advanced recurrent tumors of different histologies with ATM loss-of-function or one of 16 STEP2-identified genomic alterations. The primary purpose of this study is to assess the safety and tolerability of niraparib or olaparib in combination with camonsertib, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of camonsertib in combination with niraparib or olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity. Visit ClinicalTrials.gov (NCT04972110) for more information about this trial. |
|
MYTHIC
Lunresertib (RP-6306-01)
Phase 1: Actively Recruiting
|
Overview:
This Phase 1, multi-center, open-label, dose-escalation study is evaluating Lunresertib (RP-6306) alone or in combination with camonsertib (RP-3500) in patients with advanced recurrent tumors of different histologies in tumors with detected CCNE1 amplification, deleterious alterations in FBXW7 and other STEP2 genes. The primary purpose of this study is to assess the safety and tolerability of Lunresertib (RP-6306) alone or in combination with camonsertib in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity. Visit ClinicalTrials.gov (NCT04855656) for more information about this trial. |
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MAGNETIC
Lunresertib (RP-6306-02) + Gemcitabine Combo
Phase 1: Actively Recruiting
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Overview:
This Phase 1, multi-center, open-label, dose-escalation study is evaluating Lunresertib (RP-6306) in patients with advanced recurrent tumors of different histologies in tumors with detected CCNE1 amplification, deleterious alterations in FBXW7 and other STEP2 genes. The primary purpose of this study is to assess the safety and tolerability of Lunresertib (RP-6306) in combination with gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of Lunresertib (RP-6306) in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity. Visit ClinicalTrials.gov (NCT05147272) for more information about this trial. |
|
MINOTAUR
Lunresertib (RP-6306-03) + FOLFIRI Combo
Phase 1: Actively Recruiting
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Overview:
This Phase 1, multi-center, open-label, dose-escalation study is evaluating Lunresertib (RP-6306) in patients with advanced recurrent tumors of different histologies in tumors with detected CCNE1 amplification, deleterious alterations in FBXW7 and other STEP2 genes. The primary purpose of this study is to assess the safety and tolerability of Lunresertib (RP-6306) with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity. Visit ClinicalTrials.gov (NCT05147350) for more information about this trial. |