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Monoclonal Antibodies
RMC-6291 + RMC-6236 for Advanced 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
Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors
Must not have
Primary central nervous system (CNS) tumors
Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if two new drugs are safe and effective to treat cancers with a specific gene mutation.
Who is the study for?
This trial is for adults with advanced solid tumors that have a specific mutation (KRAS G12C). Participants must have tried other treatments like immunotherapy and chemotherapy. They should be in good physical condition, but can't join if they've had recent surgery or active brain metastases.
What is being tested?
The study tests the combination of two drugs, RMC-6291 and RMC-6236, on patients with KRAS G12C-mutated tumors to assess safety, how well the body tolerates them, and how the body processes these drugs.
What are the potential side effects?
While not explicitly listed here, common side effects for cancer drug trials may include nausea, fatigue, liver issues, skin reactions and potential complications from lowered immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be cured with surgery, and has a specific KRAS mutation.
Select...
I have NSCLC and was treated with immunotherapy, chemotherapy, and KRAS G12C inhibitors.
Select...
I have NSCLC with small, symptom-free brain metastases and have had immunotherapy or chemotherapy.
Select...
I am fully active or can carry out light work.
Select...
My solid tumor has not been treated with KRAS G12C inhibitors.
Select...
I have NSCLC treated with immunotherapy and chemotherapy but not with KRAS G12C inhibitors.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer originated in the brain or spinal cord.
Select...
I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.
Select...
I have a digestive issue that affects how my body absorbs medicine.
Select...
I have active cancer spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 and RMC-6236
Disease Control Rate
Duration of Response (DOR)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: RMC-6291 and RMC-6236Experimental Treatment1 Intervention
Dose escalation and Dose expansion
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Who is running the clinical trial?
Revolution Medicines, Inc.Lead Sponsor
12 Previous Clinical Trials
2,872 Total Patients Enrolled
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