Study on RP-3500 (Camonsertib) for Advanced Solid Tumors

Sponsor: Repare Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04497116

Provider View

This clinical trial is testing a new drug, RP-3500 (Camonsertib), alone or with other medications, to find the best dose and schedule for treating advanced solid tumors. The study will also check the safety and effectiveness of these treatments.

Patient Parameters

Program Overview

The main goal of this study is to find the best dose and schedule for a new drug called RP-3500 (Camonsertib) when used alone or with other drugs like talazoparib or gemcitabine in patients with advanced solid tumors. Researchers will also look at how safe and tolerable the drug is, how it moves and works in the body, and its ability to shrink tumors.

Description

This study is the first time RP-3500 (Camonsertib) is being tested in humans. It is a Phase 1/2a study conducted at multiple centers. The study will start by testing RP-3500 (Camonsertib) alone to find the safest dose. Then, it will test the drug in combination with talazoparib or gemcitabine. Researchers will monitor how the drug is absorbed and processed in the body and its effects on tumors. The study will also look at how the drug interacts with certain biomarkers in the body. Once the best dose is found, more patients will be enrolled to further study the drug's effects and safety.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a confirmed diagnosis of solid tumors that do not respond to standard treatments.
  • Must have measurable disease according to specific criteria.
  • Must have a biomarker profile from a certified lab.
  • Must be able to provide a tumor tissue sample.
  • Must be able to follow study procedures and take oral medications.
  • Must have acceptable organ function and blood counts.
  • Women of childbearing potential must have a negative pregnancy test and use contraception during the study and for 6 months after.
  • Must have resolved any side effects from previous treatments.
  • Men must use contraception and refrain from donating sperm during the study and for 6 months after.

Exclusion Criteria

  • Cannot have received chemotherapy or other cancer treatments within 14 days before starting the study.
  • Cannot have conditions or treatments that might interfere with the study.
  • Cannot have previously taken ATR or DNA-PK inhibitors.
  • Cannot be allergic to RP-3500 (Camonsertib) ingredients.
  • Cannot have life-threatening illnesses or uncontrolled infections.
  • Cannot have uncontrolled brain metastases or high blood pressure.
  • Cannot have active infections like hepatitis B, C, or HIV.
  • Cannot have moderate or severe liver problems.
  • Cannot have significant heart issues or abnormal ECGs.
  • Cannot be taking medications that prolong the QT interval.
  • Cannot have a history of certain blood disorders like MDS or AML.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.