RMC-6291 for Solid Cancers

Not currently recruiting at 76 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RMC-6291 to evaluate its safety and effectiveness for individuals with certain advanced solid tumors. The focus is on tumors with a specific mutation called KRASG12C, which cannot be treated with regular surgery and have resisted other treatments. The study seeks participants who have these types of cancers and have either tried other treatments without success or cannot undergo standard treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that RMC-6291 is likely to be safe for humans?

Research shows that RMC-6291 is being tested for safety in treating solid tumors. In a study with 47 patients who have a specific gene mutation (KRASG12C), 35 patients continued the treatment, suggesting it might be well-tolerated. This ongoing research aims to find the optimal dose that patients can handle without major issues. Although it's still early, the continued participation of many patients suggests potential safety. As this study is in its early stages, researchers are still gathering important safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

RMC-6291 is unique because it specifically targets KRAS mutations, which are common in many solid tumors but notoriously difficult to treat. Unlike traditional chemotherapy, which can damage both cancerous and healthy cells, RMC-6291 aims to block the mutant KRAS protein directly, potentially reducing side effects and improving effectiveness. Researchers are excited about this treatment because targeting KRAS directly could lead to more precise and effective treatment options for patients with these challenging cancers.

What evidence suggests that RMC-6291 might be an effective treatment for solid cancers?

Research has shown that RMC-6291, the investigational treatment in this trial, holds promise for treating solid tumors with the KRAS G12C mutation. In studies, this drug has proven effective, particularly for non-small cell lung cancer (NSCLC). Patients with recent KRAS G12C mutations have shown positive responses, with signs of tumor shrinkage. Early results suggest the drug may help control disease progression. Thus, RMC-6291 could be a viable treatment option for individuals with these advanced cancers. ^{1 2 3 5 6}

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. ir.revmed.com ir.revmed.com/news-releases/news-release-details/revolution-medicines-present-updated-elironrasib-safety-and

Revolution Medicines to Present Updated Elironrasib ... Advancing RAS(ON) Inhibitor Platform Across Tumor Types · About Non-Small Cell Lung Cancer · About Revolution Medicines, Inc.

2. aacrjournals.org aacrjournals.org/mct/article/22/12_Supplement/PR014/730400/Abstract-PR014-Preliminary-safety-and-anti-tumor

Preliminary safety and anti-tumor activity of RMC-6291, a first ... Conclusions This preliminary data set shows promising anti-tumor activity of RMC-6291 in KRASG12C-mutated NSCLC with recent prior KRASG12C ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06128551

NCT06128551 | Study of RMC-6291 in Combination with ... This study is to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors. ... Cancers. J Med ...

4. onclive.com onclive.com/view/dr-hong-on-preliminary-activity-with-rmc-6291-in-advanced-kras-g12c-mutant-solid-tumors

Dr Hong on Preliminary Activity With RMC-6291 in ... PER® Liver Cancer Tumor Board: How Do Evolving Data for Immune-Based Strategies. Video. PER® Liver Cancer Tumor Board: How Do Evolving Data ...

5. revmed.com revmed.com/wp-content/uploads/2023/10/ENA_2023_RMC-6291.pdf

Preliminary Safety and Anti-Tumor Activity of RMC-6291, a ... ... cancer; ctDNA, circulating tumor DNA; CYPA, cyclophilin A; D, day; DCR, disease control rate;. DLT, dose-limiting toxicity; ECG ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05462717

Study Details | NCT05462717 | Dose Escalation and ... The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) ...