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KRAS G12C(ON) inhibitor

RMC-6291 for Solid Cancers

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a new drug for safety and how well it works in people with advanced solid tumors.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Dose Limiting Toxicities

Secondary outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor

10 Previous Clinical Trials

1,840 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned RMC-6291 for use yet?

"As this is a Phase 1 trial, and thus limited data exists to support its safety or efficacy, our team at Power assigned RMC-6291 a score of 1."

Answered by AI

Is the enrollment phase of this clinical trial still open?

"Affirmative. According to the details available on clinicaltrials.gov, this medical experiment is currently looking for people to take part in it; having been posted at the 19th of September 2022 and modified a day later. 117 test subjects are being sought from 6 distinct sites today."

Answered by AI

What is the current scope of implementation for this clinical trial?

"Patients are being enrolled in this clinical trial at multiple sites, including START in San Antonio, TX; Next Oncology Virginia in Fairfax, VA; and Highlands Oncology Group in Springdale, AK."

Answered by AI

What outcomes is the clinical trial seeking to accomplish?

"Over the span of 21 days (Cycle 1), this trial will track adverse events. Additional metrics include Tmax, which stands for Time to Reach Maximum Blood Concentration of RMC-6291, DCR or Disease Control Rate per RECIST v1.1, and finally DOR or Duration of Response per RECIST v1.1."

Answered by AI

How many subjects are currently receiving the treatment being tested in this trial?

"The study requires 117 qualified volunteers to take part, who can come from either the START San Antonio center in Texas or Next Oncology Virginia in Fairfax."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

2022. "Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462717.

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