Avutometinib + Adagrasib for Lung Cancer
(RAMP204 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of two drugs, avutometinib (a Raf/MEK inhibitor) and adagrasib (also known as Krazati), to determine their safety and effectiveness for people with G12C Non-Small Cell Lung Cancer (NSCLC). The focus is on patients whose cancer has continued to grow despite other G12C inhibitor treatments. It suits those with the KRAS G12C mutation who have undergone some, but not excessive, prior treatments. Participants should have manageable health conditions and be able to take oral medications. As a Phase 1, Phase 2 trial, this study aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.
Do I need to stop my current medications to join the trial?
The trial requires you to stop taking certain medications, like strong CYP3A4 inhibitors or inducers, and strong inhibitors of breast cancer resistance protein (BCRP), at least 14 days before starting the study. If you're on these medications, you may need to discuss alternatives with your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the drugs avutometinib (VS-6766) and adagrasib are being tested together to assess their safety for people with lung cancer. Earlier studies with similar drug combinations have shown promising results. Most patients have tolerated the treatments well. Some side effects have been reported, but they are usually mild to moderate.
Common side effects might include fatigue, nausea, or mild skin rashes, which are typical for cancer treatments. Importantly, studies involving avutometinib have not commonly reported severe or life-threatening effects.
The current study aims to find the best dose for the combination of avutometinib and adagrasib. Researchers are adjusting the treatment to reduce side effects and increase benefits. This step is crucial to ensure the treatment's safety before wider use.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Avutometinib (VS-6766) and Adagrasib for lung cancer because these drugs target cancer cells in a novel way. Unlike standard treatments that may focus on broad chemotherapy or radiation, Avutometinib plus Adagrasib specifically aim at inhibiting the KRAS G12C mutation, a common driver in certain lung cancers. This targeted approach could potentially improve outcomes for patients who have previously been exposed to G12C inhibitors by directly disrupting the cancer's growth signals. The specificity of this mechanism offers hope for more effective and personalized cancer therapies.
What evidence suggests that this treatment might be an effective treatment for lung cancer?
Research has shown that combining two drugs, avutometinib (VS-6766) and adagrasib, may help treat G12C Non-Small Cell Lung Cancer (NSCLC). Avutometinib blocks proteins that promote cancer cell growth, while adagrasib targets a specific mutation in the cancer cells called KRAS G12C, common in this type of lung cancer. This trial will assess the effectiveness of this combination in patients previously exposed to G12C inhibitors. Studies have found that these drugs together can halt cancer cell growth in patients who have tried other treatments. Early results suggest this combination could be a promising treatment option for patients with this mutation.13467
Who Is on the Research Team?
MD Verastem
Principal Investigator
Verastem, Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
To determine the recommended phase 2 dose (RP2D) for VS-6766 in combination with adagrasib
Treatment Part B
To determine the efficacy of the RP2D identified from Part A
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Adagrasib
- Avutometinib (VS-6766)
Adagrasib is already approved in United States, European Union for the following indications:
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
- KRAS G12C-mutated locally advanced or metastatic colorectal cancer
- KRAS G12C mutation non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verastem, Inc.
Lead Sponsor
Mirati Therapeutics Inc.
Industry Sponsor
Dr. Charles M. Baum
Mirati Therapeutics Inc.
Chief Executive Officer since 2023
MD, PhD
Dr. Joseph Leveque
Mirati Therapeutics Inc.
Chief Medical Officer since 2021
MD