RMC-9805 for Solid Cancers

Recruiting at 16 trial locations

Overseen By Revolution Medicines, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Revolution Medicines, Inc.

Must not be taking: KRAS inhibitors

Disqualifiers: CNS tumors, Brain metastases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 weeks

444 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral drug, RMC-9805, in adults with a specific type of cancer mutation (KRAS G12D). The drug aims to block a faulty gene to potentially stop cancer growth.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Revolution Medicines, Inc.

Principal Investigator

Revolution Medicines, Inc.

Eligibility Criteria

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without success or could not tolerate them, and should be in fairly good health (ECOG status 0 or 1) with their organs working well. People can't join if they have issues absorbing pills, brain tumors, active brain metastases, spinal cord compression, or previous treatment with similar investigational drugs.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer is advanced or has spread, and tests show a KRASG12D mutation.

My cancer has worsened or I couldn't tolerate the standard treatments.

Exclusion Criteria

I have or might have cancer spread to my brain, spinal cord, or its coverings.

I have been treated with drugs targeting the KRASG12D mutation or similar.

I have issues with my digestive system that might affect my ability to take pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RMC-9805 as monotherapy or in combination with RMC-6236, including dose exploration and dose expansion

21 weeks

Follow-up

Participants are monitored for safety, tolerability, and clinical activity after treatment

up to 3 years

Treatment Details

Interventions

• RMC-9805

Trial Overview The study tests the safety and how well people can handle RMC-9805 in those who have certain types of cancer like lung, colorectal, pancreatic cancer etc., all of which share the KRAS G12D mutation. The main goal is to see what happens when patients take this new drug.

Participant Groups

Group I: RMC-9805 plus RMC-6236 combination arm Experimental Treatment 2 Interventions

Dose exploration and dose expansion

Group II: RMC-9805 monotherapy arm Experimental Treatment 1 Intervention

Dose exploration and dose expansion

Who Is Running the Clinical Trial?

Revolution Medicines, Inc.

Lead Sponsor

Trials

14

Recruited

4,500+