RMC-6291 for Solid Cancers

Recruiting at 64 trial locations

Overseen By Revolution Medicines, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Revolution Medicines, Inc.

Must not be taking: KRASG12C (ON) inhibitors

Disqualifiers: Primary CNS tumors, Active brain metastases, others

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

Compensation: Varies

Number of Visits: Unknown

222 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, RMC-6291, in adults with advanced cancers that have a specific mutation. The drug aims to block a faulty protein in these cancer cells to stop their 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.

What makes the drug RMC-6291 unique for treating solid cancers?

RMC-6291 is unique because it targets specific components of cancer cells, potentially involving mechanisms related to ribonucleotide reductase subunits like RRM2B, which have been associated with better survival outcomes in certain cancers. This approach may offer a novel way to suppress cancer cell invasiveness and improve patient prognosis compared to traditional treatments. ^{1 2 3 4 5}

Who Is on the Research Team?

Revolution Medicines, Inc.

Principal Investigator

Revolution Medicines, Inc.

Are You a Good Fit for This Trial?

Adults over 18 with advanced solid tumors that have a specific mutation (KRASG12C) can join. They should have tried standard treatments, be in fairly good health, and able to do daily activities. Not for those who've had recent surgery or brain tumors/metastases.

Inclusion Criteria

I have been treated with a KRASG12C inhibitor before.

My cancer has a specific KRASG12C mutation and cannot be removed by surgery.

I am fully active or can carry out light work.

Exclusion Criteria

I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

I have been treated with a KRASG12C inhibitor before.

I have a digestive issue that affects how my body absorbs medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of RMC-6291 to evaluate safety, tolerability, and pharmacokinetics

21 days (Cycle 1)

Dose Expansion

Participants receive the recommended Phase 2 dose of RMC-6291 to further evaluate safety and efficacy

up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RMC-6291

Trial Overview The trial is testing RMC-6291, a new drug targeting the KRAS G12C mutation in cancer cells. It's given alone to find the safest high dose and best dose for Phase 2 trials based on how patients react and what levels of the drug appear in their blood.

How Is the Trial Designed?

Group I: RMC-6291 Experimental Treatment 1 Intervention

Dose Escalation and Dose Expansion

Who Is Running the Clinical Trial?

Revolution Medicines, Inc.

Lead Sponsor

Trials

14

Recruited

4,500+

Published Research Related to This Trial

High levels of RRM2B expression in colorectal cancer (CRC) patients are linked to significantly better survival rates, particularly in advanced stage IV patients, as shown in a study involving 323 CRC cases.

In a mouse model, overexpression of RRM2B in nonmetastatic CRC cells effectively prevented metastasis to the lungs and liver, indicating its potential role in suppressing cancer cell invasiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ribonucleotide reductase small subunit M2B prognoses better survival in colorectal cancer. Liu, X., Lai, L., Wang, X., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Ribonucleotide reductase small subunit M2 serves as a prognostic biomarker and predicts poor survival of colorectal cancers. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Predictive and Prognostic Value of Ribonucleotide Reductase Regulatory Subunit M1 and Excision Repair Cross-Complementation Group 1 in Advanced Urothelial Carcinoma (UC) Treated with First-Line Gemcitabine Plus Platinum Combination Chemotherapy. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Comprehensive Landscape of RRM2 with Immune Infiltration in Pan-Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ribonucleotide reductase small subunit M2B prognoses better survival in colorectal cancer. [2021]

5. Greece pubmed.ncbi.nlm.nih.gov

High RRM1 Expression Is Associated with Adverse Outcome in Patients with Cisplatin/Vinorelbine-treated Malignant Pleural Mesothelioma. [2020]