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RAS Inhibitor

RAS(ON) Inhibitors for Gastrointestinal Cancer

Phase 1 & 2
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
≥ 18 years of age
Must have pathologically documented, pancreatic carcinoma with documented metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A and B)
Must not have
Primary central nervous system (CNS) tumors
Major surgery within 28 days of first dose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial is testing new drugs that inhibit RAS(ON) combined with standard treatments or other new drugs to see if they are safe, tolerated, and effective against tumors. There are three different parts

Who is the study for?
This trial is for adults over 18 with specific gastrointestinal cancers, including metastatic pancreatic carcinoma or RAS-mutated colorectal adenocarcinoma. Participants must be in good physical condition (ECOG PS 0-1) and have proper organ function. It's not suitable for those with primary brain tumors or GI issues affecting drug absorption, or who've had major surgery within the last month.
What is being tested?
The study tests new RAS(ON) inhibitors combined with standard cancer treatments or novel agents in three subprotocols: A) RMC-6236 plus fluorouracil-based regimens; B) RMC-6236 plus cetuximab, optionally with mFOLFOX6; C) RMC-6234 plus gemcitabine and nab-paclitaxel. The goal is to assess safety, tolerability, how the body processes the drugs (PK), and initial effectiveness against tumors.
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased infection risk, adverse effects from chemotherapy like nausea and fatigue, allergic responses to monoclonal antibodies like cetuximab, and possible complications from combining multiple treatments.

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 pancreatic cancer with spread or colorectal cancer that cannot be surgically removed.
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My pancreatic cancer is aggressive and has spread to other parts.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer originated in the brain or spinal cord.
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I have not had major surgery in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
DCR
DOR
ORR
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Subprotocol C: metastatic PDACExperimental Treatment3 Interventions
RMC-6236 (QD) and Gemcitabine with Nab-paclitaxel
Group II: Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDACExperimental Treatment3 Interventions
RMC-6236 (QD) and Cetuximab with or without mFOLFOX6
Group III: Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDACExperimental Treatment4 Interventions
RMC-6236 (QD) and Bevacizumab with 5-fluorouracil-based regimens
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFOX6 regimen
2018
Completed Phase 2
~40
gemcitabine
2013
Completed Phase 3
~4260
cetuximab
2000
Completed Phase 3
~7290
nab-paclitaxel
2008
Completed Phase 4
~1430
bevacizumab
2002
Completed Phase 3
~3360

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor
11 Previous Clinical Trials
2,216 Total Patients Enrolled
Study DirectorStudy DirectorRevolution Medicines
1,252 Previous Clinical Trials
503,973 Total Patients Enrolled
~271 spots leftby May 2027
Unbiased ResultsWe believe in providing patients with all the options.
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