222 Participants Needed

RMC-6291 for Solid Cancers

Recruiting at 64 trial locations
RM
Overseen ByRevolution Medicines, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

Research Team

RM

Revolution Medicines, Inc.

Principal Investigator

Revolution Medicines, Inc.

Eligibility Criteria

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 am 18 years old or older.
I have been treated with a KRASG12C inhibitor before.
My cancer has a specific KRASG12C mutation and cannot be removed by surgery.
See 2 more

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.
See 2 more

Timeline

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

Treatment Details

Interventions

  • RMC-6291
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: RMC-6291Experimental Treatment1 Intervention
Dose Escalation and Dose Expansion

Find a Clinic Near You

Who Is Running the Clinical Trial?

Revolution Medicines, Inc.

Lead Sponsor

Trials
14
Recruited
4,500+

Findings from Research

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

References

Ribonucleotide reductase small subunit M2 serves as a prognostic biomarker and predicts poor survival of colorectal cancers. [2021]
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]
Comprehensive Landscape of RRM2 with Immune Infiltration in Pan-Cancer. [2022]
Ribonucleotide reductase small subunit M2B prognoses better survival in colorectal cancer. [2021]
High RRM1 Expression Is Associated with Adverse Outcome in Patients with Cisplatin/Vinorelbine-treated Malignant Pleural Mesothelioma. [2020]