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G12C Inhibitor
Avutometinib + Adagrasib for Lung Cancer (RAMP204 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
An Eastern Cooperative Group (ECOG) performance status ≤ 1
The subject must have received prior therapy with a KRAS G12C inhibitor and experienced progression
Must not have
Concurrent ocular disorders
Subjects with the inability to swallow oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing a combination of two drugs, avutometinib (VS-6766) and adagrasib, in patients with a specific type of lung cancer who have not responded to previous treatments. The drugs aim to stop the cancer cells from growing by blocking the signals that tell them to multiply. Adagrasib, a KRASG12C inhibitor, irreversibly and selectively binds KRASG12C, locking it in its inactive state.
Who is the study for?
This trial is for adults with a specific mutation in their lung cancer (KRAS G12C) who have tried but not responded to certain treatments. They should be relatively healthy, able to perform daily activities with ease, and must not have more than three previous cancer treatments or active infections like hepatitis or HIV.
What is being tested?
The study tests the combination of two drugs, avutometinib (VS-6766) and adagrasib, on patients whose non-small cell lung cancer has worsened after initial treatment. It aims to see if this drug combo is safe and works better for these patients.
What are the potential side effects?
Possible side effects may include typical reactions from cancer medications such as fatigue, digestive issues, skin problems, changes in blood counts leading to increased infection risk or bleeding tendencies. Specific risks related to these drugs will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
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I have been treated with a KRAS G12C inhibitor and my cancer has progressed.
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My cancer has a KRAS G12C mutation.
Select...
My lung cancer diagnosis was confirmed by lab tests.
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I've had 1-3 treatments for advanced lung cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an eye condition.
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I cannot swallow pills.
Select...
I have not had major surgery in the last 4 weeks.
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I needed treatment for brain metastases symptoms within the last 2 weeks.
Select...
I have heart disease or severe lung problems.
Select...
I have an active hepatitis B, C, or HIV infection.
Select...
I have had rhabdomyolysis or lung disease in the past.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: To determine RP2D for avutometinib(VS-6766) in combination with adagrasib
To determine the efficacy of the optimal regimen identified from Part A
Secondary outcome measures
Clinical Benefit Rate
Disease Control Rate (DCR)
Duration of Response (DOR)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: avutometinib(VS-6766)+adagrasibExperimental Treatment1 Intervention
To determine the recommended phase 2 dose (RP2D) for VS-6766 in combination with adagrasib in G12C inhibitor exposed patients
Group II: avutometinib (VS-6766)+adagrasib RP2DExperimental Treatment1 Intervention
To determine the efficacy of the RP2D identified from Part A in G12C inhibitor exposed patients
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
Common treatments for lung cancer often involve targeted therapies that inhibit specific genetic mutations and signaling pathways critical for cancer cell proliferation and survival. For instance, Avutometinib (VS-6766) targets the RAF/MEK pathway, while Adagrasib inhibits the KRAS G12C mutation.
These targeted approaches are significant for lung cancer patients because they offer more personalized and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
Sotorasib: a treatment for non-small cell lung cancer with the KRAS G12C mutation.Trials to Overcome Drug Resistance to EGFR and ALK Targeted Therapies - Past, Present, and Future.Tailoring tyrosine kinase inhibitors to fit the lung cancer genome.
Sotorasib: a treatment for non-small cell lung cancer with the KRAS G12C mutation.Trials to Overcome Drug Resistance to EGFR and ALK Targeted Therapies - Past, Present, and Future.Tailoring tyrosine kinase inhibitors to fit the lung cancer genome.
Find a Location
Who is running the clinical trial?
Verastem, Inc.Lead Sponsor
39 Previous Clinical Trials
2,533 Total Patients Enrolled
Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
8,044 Total Patients Enrolled
Hagop Youssoufian, MDStudy DirectorVerastem, Inc.
24 Previous Clinical Trials
1,662 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an eye condition.I am fully active and can carry on all my pre-disease activities without restriction.I had cancer before, but it was successfully treated.I cannot swallow pills.My organs are working well.I haven't taken strong BCRP inhibitors recently.I have recovered from side effects of my previous cancer treatments.I have not had COVID-19 in the last 28 days.I have been treated with a KRAS G12C inhibitor and my cancer has progressed.I have not had major surgery in the last 4 weeks.My cancer has a KRAS G12C mutation.I needed treatment for brain metastases symptoms within the last 2 weeks.I have heart disease or severe lung problems.My lung cancer diagnosis was confirmed by lab tests.I haven't taken strong CYP3A4 affecting drugs recently.I am 18 years old or older.I've had 1-3 treatments for advanced lung cancer.I have an active hepatitis B, C, or HIV infection.I have had a skin condition that needed treatment through the bloodstream in the last year.I haven't had cancer treatments or experimental drugs recently.You have a disease that can be measured using specific guidelines.I have had rhabdomyolysis or lung disease in the past.
Research Study Groups:
This trial has the following groups:- Group 1: avutometinib(VS-6766)+adagrasib
- Group 2: avutometinib (VS-6766)+adagrasib RP2D
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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