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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 belowSelect...
My advanced cancer has specific KRAS G12 or RAS mutations.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
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 moreTrial 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)
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 EGFR inhibitors (e.g., osimertinib) and ALK inhibitors (e.g., crizotinib), work by specifically targeting genetic mutations that drive cancer growth, leading to more effective and personalized treatment.
Immunotherapies, like pembrolizumab, enhance the body's immune response against cancer cells by targeting PD-1/PD-L1 pathways. Chemotherapy, using agents like pemetrexed and carboplatin, kills rapidly dividing cancer cells but can also affect normal cells.
For patients with specific mutations like KRAS, emerging treatments such as RAS inhibitors (e.g., RMC-6236) are being studied to directly inhibit the RAS pathway, which is crucial for cancer cell proliferation and survival. Understanding these mechanisms allows for more precise and effective treatment strategies, improving outcomes and reducing side effects for NSCLC patients.
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Who is running the clinical trial?
Revolution Medicines, Inc.Lead Sponsor
11 Previous Clinical Trials
1,994 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious health issues that could affect my safety or participation in the study.My organs are working well.I have issues with my digestive system that might affect my ability to take pills.I have received the standard treatment for my cancer type and stage.My advanced cancer has specific KRAS G12 or RAS mutations.My cancer originated in the brain or spinal cord.I have brain metastases that haven't been treated.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: RMC-6236
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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