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Small Molecule Inhibitor

RMC-6236 for Cancer

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
Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Study Summary

This trial will test how well a new drug, RMC-6236, works in adults with advanced solid tumors that have a specific type of KRAS gene mutation.

Who is the study for?
This trial is for adults with advanced solid tumors that have specific RAS mutations, who've already tried standard treatments. They need to be relatively healthy and active (ECOG status of 0 or 1), with good organ function. It's not for those with primary brain tumors, untreated brain metastases, issues absorbing oral meds, or other serious health problems.Check my eligibility
What is being tested?
The study tests the safety and how well people tolerate RMC-6236, a new medication aimed at treating various types of cancer like lung and colorectal cancer that have certain genetic changes known as RAS mutations.See study design
What are the potential side effects?
While the side effects of RMC-6236 are being studied in this trial and aren't fully known yet, they may include typical reactions to cancer medications such as nausea, fatigue, liver issues, skin reactions and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has specific KRAS G12 or RAS mutations.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs
Number of Participants with Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Area Under Blood Concentration Time Curve (AUC) of RMC-6236
Disease Control Rate (DCR)
Duration of Response (DOR)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: RMC-6236Experimental Treatment1 Intervention
Enrollment into dose exploration may be from any advanced solid tumor type with KRAS p.G12 mutations. Enrollment into dose expansion/optimization may be from groups consisting of patients with a single histotype/genotype (for example, KRAS G12-mutated NSCLC, PDAC, CRC, RAS mutant NSCLC, PDAC, CRC, Melanoma, gynecological cancer or other solid tumors not previously specified). RAS mutant is defined as any nonsynonymous mutation of KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor
10 Previous Clinical Trials
1,588 Total Patients Enrolled

Media Library

RMC-6236 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05379985 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Experimental: RMC-6236
Non-Small Cell Lung Cancer Clinical Trial 2023: RMC-6236 Highlights & Side Effects. Trial Name: NCT05379985 — Phase 1
RMC-6236 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05379985 — Phase 1

Frequently Asked Questions

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

How many sites are conducting this experiment?

"The Mary Crowley Cancer Research Institute in Dallas, Texas; the Dana Farber Cancer Institute of Boston, Massachusetts; and Sarah Cannon Research Institute in Nashville, Tennessee all serve as clinical trial hubs for this endeavor. In addition to these locations, there are 10 other sites active in this study."

Answered by AI

To what extent has the recruitment been for this experiment?

"Revolution Medicines, Inc. is seeking 141 participants who meet the study's eligibility criteria in order to carry out the trial at Mary Crowley Cancer Research (Dallas, Texas) and Dana Farber Cancer Institute (Boston, Massachusetts)."

Answered by AI

Has the United States Food and Drug Administration sanctioned RMC-6236?

"As RMC-6236 is a stage 1 trial with limited evidence of safety and efficacy, it has been rated as a one on the scale."

Answered by AI

Is the patient enrollment phase of this research still available?

"According to public records, this clinical trial is actively recruiting participants. Initially posted on May 31th 2022 and most recently updated on September 9th 2022, the study has been extended for a longer period of time."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What site did they apply to?
Memorial Sloan-Kettering Cancer Center
The University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have had chemotherapy but it has stopped because of kidney injury from the drugs. So I’m seekin g for alternative methods to control the disease.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
2022. "Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05379985.
All > Colorectal Cancer San Diego
~20 spots leftby Jun 2024
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