Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

Recruiting at 11 trial locations

Overseen By Revolution Medicines, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Revolution Medicines, Inc.

Disqualifiers: Brain metastases, CNS tumors, Cardiac disease, Lung disease, Retinal conditions, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

133 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

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

What is the purpose of this trial?

This trial is testing a drug called RMC-4630 on adults whose solid tumors have come back or didn't respond to previous treatments. The drug aims to slow or stop tumor growth by targeting a specific overactive pathway in cancer cells.

Research Team

Revolution Medicines, Inc.

Principal Investigator

Revolution Medicines, Inc.

Eligibility Criteria

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Participants in the Dose-Expansion Component must have one of the following genotypic aberrations: KRAS amplifications, KRASG12C (NSCLC), BRAF Class 3, or NF1 LOF (NSCLC and gynecological cancers) mutations

Participant able to understand and voluntarily sign the informed consent form (ICF) and able to comply with the study visit schedule and other protocol requirements.

Exclusion Criteria

Known HIV infection

Females who are pregnant or breastfeeding

Known or suspected leptomeningeal or brain metastases or spinal cord compression

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Participants receive escalating doses of RMC-4630 to evaluate safety, tolerability, and pharmacokinetics

28 days

Dose-Expansion

Participants with specific mutations receive RMC-4630 to further evaluate safety and efficacy

up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RMC-4630

Participant Groups

Group I: RMC-4630 Experimental Treatment 1 Intervention

RMC-4630 for oral administration

Who Is Running the Clinical Trial?

Revolution Medicines, Inc.

Lead Sponsor

Trials

14

Recruited

4,500+

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University