RP-1664 for Cancer

Recruiting at 4 trial locations

Overseen By Joseph O'Connell, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Repare Therapeutics

Must not be taking: QT prolonging drugs

Disqualifiers: Uncontrolled infection, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral drug called RP-1664, which blocks a protein that helps cancer cells grow. It targets patients with advanced solid tumors who need new treatment options. The goal is to find a safe dose and see if the drug can slow or stop tumor growth.

Will I have to stop taking my current medications?

The trial requires stopping certain medications, such as chemotherapy or biologic agents, at least 21 days before starting. Also, you cannot be on medications that prolong the QT interval (a heart rhythm measure).

Eligibility Criteria

This trial is for men and women aged 12 or older with advanced solid tumors that have worsened after treatment, or didn't respond to previous therapies. They should be able to perform daily activities with ease or only slight difficulty (ECOG score of 0-1), have a life expectancy of at least 4 months, and must have measurable disease according to specific criteria. Participants under 18 must weigh at least 40 kg.

Inclusion Criteria

My organs are functioning well.

Use of highly effective forms of contraception

Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments

Exclusion Criteria

Uncontrolled high blood pressure

I haven't had cancer treatment with drugs in the last 3 weeks.

I started RANKL inhibitor treatment less than 4 months ago. Bisphosphonates were started at least 28 days before joining.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Participants receive escalating doses of RP-1664 to evaluate safety and determine the maximum tolerated dose (MTD)

8-12 weeks

Expansion Cohorts

Participants with molecularly selected advanced solid tumors receive RP-1664 at the recommended phase 2 dose (RP2D) to assess anti-tumor effect and further examine safety and pharmacokinetics

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RP-1664

Trial Overview The study is testing the safety and appropriate dose of RP-1664, an oral drug designed to inhibit PLK4, which may play a role in tumor cell growth. It will also look into how the body processes the drug (pharmacokinetics), how it affects the body (pharmacodynamics), and its preliminary effectiveness against tumors.

Participant Groups

Group I: RP-1664 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Repare Therapeutics

Lead Sponsor

Trials

10

Recruited

1,300+