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KRAS G12C(ON) inhibitor

RMC-6291 for Solid Cancers

Phase 1
Waitlist Available
Research Sponsored by Revolution Medicines, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be ≥18 years of age.
Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
Must not have
Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
Prior therapy with KRASG12C (ON) inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include issues related to organ inflammation, reactions at the infusion site, tiredness, stomach problems like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been treated with a KRASG12C inhibitor before.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.
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I have been treated with a KRASG12C inhibitor before.
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I have a digestive issue that affects how my body absorbs medicine.
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My cancer originated in the brain or spinal cord.
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I have active cancer spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Dose Limiting Toxicities
Secondary study objectives
Area Under Blood Concentration Time Curve of RMC-6291
Disease Control Rate (DCR)
Duration of Response (DOR)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RMC-6291Experimental Treatment1 Intervention
Dose Escalation and Dose Expansion

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as sotorasib and adagrasib, specifically inhibit the KRAS G12C mutation by locking the KRAS protein in its inactive state, thereby preventing cancer cell proliferation. This is particularly relevant for patients with KRAS G12C mutations, as these therapies offer a more personalized and effective treatment option compared to traditional chemotherapy. Immunotherapies, like pembrolizumab, enhance the immune system's ability to recognize and destroy cancer cells by targeting PD-1/PD-L1 pathways. Chemotherapy, using drugs like cisplatin and paclitaxel, works by killing rapidly dividing cells but lacks the specificity of targeted treatments. Understanding these mechanisms helps in selecting the most appropriate and effective treatment for NSCLC patients based on their specific genetic mutations and overall health condition.
Sotorasib: a treatment for non-small cell lung cancer with the KRAS G12C mutation.

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor
11 Previous Clinical Trials
2,400 Total Patients Enrolled

Media Library

RMC-6291 (KRAS G12C(ON) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05462717 — Phase 1
Non-Small Cell Lung Cancer Clinical Trial 2023: RMC-6291 Highlights & Side Effects. Trial Name: NCT05462717 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: RMC-6291
RMC-6291 (KRAS G12C(ON) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462717 — Phase 1
~0 spots leftby Nov 2024