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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

RAMP204 Trial Summary

This trial will study a new combination therapy for patients with lung cancer who have progressed despite previous treatment with a similar drug.

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.Check my eligibility

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.See study design

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.

RAMP204 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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My lung cancer diagnosis was confirmed by lab tests.

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I've had 1-3 treatments for advanced lung cancer.

RAMP204 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more

RAMP204 Trial 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Verastem, Inc.Lead Sponsor

38 Previous Clinical Trials

2,513 Total Patients Enrolled

Mirati Therapeutics Inc.Industry Sponsor

70 Previous Clinical Trials

8,120 Total Patients Enrolled

Hagop Youssoufian, MDStudy DirectorVerastem, Inc.

24 Previous Clinical Trials

1,662 Total Patients Enrolled

Media Library

Adagrasib (G12C Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05375994 — Phase 1 & 2

Lung Cancer Research Study Groups: avutometinib(VS-6766)+adagrasib, avutometinib (VS-6766)+adagrasib RP2D

Lung Cancer Clinical Trial 2023: Adagrasib Highlights & Side Effects. Trial Name: NCT05375994 — Phase 1 & 2

Adagrasib (G12C Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05375994 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what locations can this trial be accessed?

"This clinical trial is being held at Medical College Wisconsin in Milwaukee, University of Colorado Hospital Anschutz Cancer Pavllion in Aurora and Virginia Cancer Specialists, NEXT Oncology in Fairfax. Additionally, the study is running across a further 5 sites."

Answered by AI

What objectives are being pursued with this experiment?

"Per the information provided by Mirati Therapeutics Inc., this trial's primary aim, to be measured over a 28-day period from treatment beginning until Reversible Posterior Leukoencephalopathy Syndrome (RP2D) has been established, is to gauge the efficacy of VS-6766 along with Adagrasib. Additionally, secondary outcomes are set to include Plasma Pharmacokinetics analysing Area Under Curve and HalfLife concentrations for Avutometinib(VS 6766), adagrasib and any relevant metabolites; as well as Duration of Response which will measure the time between initial response and Progression Disease according to"

Answered by AI

Are there still vacancies in this trial for participants?

"According to the clinicaltrials.gov listing, this trial is still open for enrollment and was last updated on November 29th 2022. It has been available since August 1st of that same year."

Answered by AI

What is the sample size of this research project?

"Affirmative, clinicaltrials.gov confirms that this medical investigation is actively enrolling patients as of 11/29/2022. The trial was initially posted on 8/1/2022 and demands 85 individuals from 5 distinct sites to participate in the research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

2022. "Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05375994.

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