RP-6306 for Advanced Cancer

(MINOTAUR Trial)

Recruiting at 13 trial locations

Overseen By Nathan Hawkey, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Repare Therapeutics

Must not be taking: Chemotherapy, Antineoplastics

Disqualifiers: Pregnancy, Uncontrolled infections, Cardiac diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 months

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the safety and effectiveness of combining a new drug, RP-6306, with standard chemotherapy (FOLFIRI) in patients with advanced cancers. The goal is to find the best dose and schedule while checking for side effects and early signs of effectiveness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy or certain cancer drugs within 21 days before starting the study treatment.

Research Team

Nathan Hawkey

Principal Investigator

Repare RX

Eligibility Criteria

Adults over 18 with advanced solid tumors like colorectal, gastrointestinal, or esophageal cancer that's getting worse despite treatment. They must be able to perform daily activities with ease or only have minor limitations (ECOG score of 0-1), and women who can have children need a negative pregnancy test.

Inclusion Criteria

My advanced cancer has not responded to standard treatments.

I am fully active or can carry out light work.

I can provide tumor tissue or am willing to undergo a biopsy if it's safe.

Exclusion Criteria

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

I cannot swallow or keep down pills.

I haven't had chemotherapy or targeted cancer drugs within the last 3 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RP-6306 in combination with FOLFIRI to determine the maximum tolerated dose and assess safety and tolerability

Up to 3 months

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• RP-6306

Trial Overview The trial is testing RP-6306 combined with FOLFIRI chemotherapy in patients with certain advanced solid tumors. It aims to find the safest dose, see how well it works against the cancer, and figure out the best dosage schedule.

Participant Groups

Group I: Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation Experimental Treatment 1 Intervention

RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)

Who Is Running the Clinical Trial?

Repare Therapeutics

Lead Sponsor

Trials

10

Recruited

1,300+