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Small Molecule Inhibitor
Avutometinib + Sotorasib for Lung Cancer (RAMP203 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Verastem, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the safety and effectiveness of VS-6766 when used with sotorasib in patients with a specific type of lung cancer.
Who is the study for?
This trial is for adults with a specific mutation in their lung cancer (G12C KRAS). They must have tried some treatments but not more than two, and can't have used a KRAS inhibitor if they want to join certain parts of the study. Participants need good organ function, no recent other cancers or severe illnesses, and agree to use birth control.
What is being tested?
The trial tests avutometinib combined with sotorasib on patients with G12C Non-Small Cell Lung Cancer. It's looking at how safe and effective this combo is for those who've had previous treatment with a G12C inhibitor and those who haven't.
What are the potential side effects?
Possible side effects include typical reactions from cancer drugs like nausea, fatigue, skin issues, liver problems, muscle pain (since there's concern about rhabdomyolysis), as well as any risks associated specifically with MEK inhibitors or Sotorasib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A: To determine RP2D for avutometinib in combination with sotorasib and the Alt-RP2D for avutometinib in combination with sotorasib and defactinib
Part B: To determine the efficacy of the RP2D and/or Alt-RP2D identified from Part A
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor naiveExperimental Treatment1 Intervention
To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor naïve patients
Group II: avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor exposedExperimental Treatment1 Intervention
To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor exposed patients
Group III: avutometinib (VS-6766)+sotorasib+defactinibExperimental Treatment1 Intervention
To determine the recommended phase 2 dose (RP2D) for avutometinib (VS-6766) in combination with sotorasib and defactinib in KRAS G12C inhibitor exposed patients
Group IV: avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor naïveExperimental Treatment1 Intervention
To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor naïve patients
Group V: avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor exposedExperimental Treatment1 Intervention
To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor exposed patients
Group VI: avutometinib (VS-6766)+sotorasibExperimental Treatment1 Intervention
To determine the recommended phase 2 dose (RP2D) for avutometinib (VS 6766) in combination with sotorasib in KRAS G12C inhibitor naïve and exposed patients
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Who is running the clinical trial?
AmgenIndustry Sponsor
1,433 Previous Clinical Trials
1,394,989 Total Patients Enrolled
Verastem, Inc.Lead Sponsor
40 Previous Clinical Trials
2,647 Total Patients Enrolled
Hagop Youssoufian, MDStudy DirectorVerastem Oncology
24 Previous Clinical Trials
1,594 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a KRAS G12C mutation.I haven't had any cancer treatments in the last 4 weeks.I've had 1-2 treatments for advanced lung cancer.I've needed treatment for a skin condition in the last year.I haven't taken strong CYP3A4 affecting drugs in the last 14 days.I am 18 years old or older.I cannot swallow pills.I have been treated with a MEK inhibitor before.I had cancer before, but it was treated and considered cured.I am not pregnant or breastfeeding.I have not had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.I have received at least one dose of a G12C inhibitor.I have had COVID-19 within the last 28 days.My lung cancer diagnosis was confirmed by lab tests.I am fully active or have some restrictions but can still care for myself.I have had rhabdomyolysis in the past.I have an eye condition.My organs are working well.I need medication or treatment for brain cancer symptoms.I have heart disease or severe lung problems.I have recovered from side effects of my previous cancer treatments.I have an active hepatitis B, C, or HIV infection.I have not taken a KRAS inhibitor for my condition.I was treated with sotorasib but had to lower the dose because of side effects.
Research Study Groups:
This trial has the following groups:- Group 1: avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor naïve
- Group 2: avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor naive
- Group 3: avutometinib (VS-6766)+sotorasib
- Group 4: avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor exposed
- Group 5: avutometinib (VS-6766)+sotorasib+defactinib
- Group 6: avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor exposed
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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