Avutometinib + Adagrasib for Lung Cancer

(RAMP204 Trial)

Recruiting at 7 trial locations

Overseen By Verastem Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Verastem, Inc.

Must not be taking: CYP3A4 inhibitors, BCRP inhibitors

Disqualifiers: Brain metastases, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

85 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

MD Verastem

Principal Investigator

Verastem, Inc.

Eligibility Criteria

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

I am fully active and can carry on all my pre-disease activities without restriction.

My organs are working well.

Agreement to use highly effective method of contraceptive

Exclusion Criteria

I have an eye condition.

I had cancer before, but it was successfully treated.

I cannot swallow pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

To determine the recommended phase 2 dose (RP2D) for VS-6766 in combination with adagrasib

4 weeks

Multiple visits for dose-limiting toxicity assessment

Treatment Part B

To determine the efficacy of the RP2D identified from Part A

16 weeks

Regular visits for response assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Periodic visits for safety and survival monitoring

Treatment Details

Interventions

• Adagrasib
• Avutometinib (VS-6766)

Trial Overview 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.

Participant Groups

Group I: avutometinib(VS-6766)+adagrasib Experimental Treatment 1 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 RP2D Experimental Treatment 1 Intervention

To determine the efficacy of the RP2D identified from Part A in G12C inhibitor exposed patients

Adagrasib is already approved in United States, European Union for the following indications:

Approved in United States as Krazati for:

• KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
• KRAS G12C-mutated locally advanced or metastatic colorectal cancer

Approved in European Union as Krazati for:

• KRAS G12C mutation non-small cell lung cancer

Who Is Running the Clinical Trial?

Verastem, Inc.

Lead Sponsor

Trials

42

Recruited

2,800+

Mirati Therapeutics Inc.

Industry Sponsor

Trials

73

Recruited

8,900+

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