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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

Known KRAS G12C mutation

Must have received appropriate treatment with at least one prior systemic regimen, but no more than 2 prior regimens, for Stage 3B-C or 4 NSCLC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

RAMP203 Trial 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.Check my eligibility

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.See study design

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.

RAMP203 Trial Eligibility Criteria

Inclusion Criteria

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

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My cancer has a KRAS G12C mutation.

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I've had 1-2 treatments for advanced lung cancer.

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I have not taken a KRAS inhibitor for my condition.

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My lung cancer diagnosis was confirmed by lab tests.

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I am fully active or have some restrictions but can still care for myself.

RAMP203 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 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 outcome measures

Disease Control Rate (DCR)

Duration of Response (DOR)

Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs)

+5 more

RAMP203 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,535 Total Patients Enrolled

Verastem, Inc.Lead Sponsor

38 Previous Clinical Trials

2,445 Total Patients Enrolled

Hagop Youssoufian, MDStudy DirectorVerastem Oncology

24 Previous Clinical Trials

1,594 Total Patients Enrolled

Media Library

Avutometinib (VS-6766) (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05074810 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor naïve, avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor naive, avutometinib (VS-6766)+sotorasib, avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor exposed, avutometinib (VS-6766)+sotorasib+defactinib, avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor exposed

Non-Small Cell Lung Cancer Clinical Trial 2023: Avutometinib (VS-6766) Highlights & Side Effects. Trial Name: NCT05074810 — Phase 1 & 2

Avutometinib (VS-6766) (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05074810 — Phase 1 & 2

Frequently Asked Questions

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

Is enrollment still open for this medical trial?

"Yes, the details on clinicaltrials.gov make clear that this medical trial is currently recruiting participants. This investigation was first published April 12th 2022 and has since been updated August 3rd of the same year. The researchers are aiming to recruit 53 individuals from 4 different locations."

Answered by AI

What medical applications are most commonly associated with VS-6766 and sotorasib?

"VS-6766 and sotorasib are often used to treat those who have undergone prior platinum based therapy, as well as for a range of other malignancies. Additionally, this duo can be prescribed for specific therapeutic procedures and one previous systemic treatment."

Answered by AI

What past research has been conducted around the usage of VS-6766 and sotorasib?

"Currently, 11 medical trials exploring the efficacy of VS-6766 and sotorasib are in progress with 1 study reaching Phase 3. 1376 clinical trial sites have been identified for these two drugs, though most are located within Sutton, Cataluña."

Answered by AI

Is this research initiative a pioneering endeavor?

"As of now, 11 active studies concerning VS-6766 and sotorasib are being conducted in 632 cities spread out across 28 countries. The first trial for these drugs was sponsored by Amgen in 2018, involving 713 patients who successfully passed the Phase 1 & 2 trials stages. Since then, 3 additional studies have been completed."

Answered by AI

Are there a multitude of facilities currently conducting this experiment within the state?

"Enrolment for this trial is occurring at 4 distinct medical centres, including locations in Boston, Saint Louis and Fairfax. It would be advisable to opt for the centre closest to you if you decide to participate in order to minimize travel commitments."

Answered by AI

What are the desired outcomes of this experiment?

"The principal assessment metric of this trial, which spans 16 weeks from the start to confirmation of response is determining RP2D for VS-6766 in combination with sotorasib. Additional metrics include Disease Control Rate (DCR), Plasma Pharmacokinetics (PK) including Tmax and Progression Free Survival (PFS)."

Answered by AI

How many participants are partaking in this clinical trial at its full capacity?

"Affirmative, clinicaltrials.gov exhibits that this experiment is actively enrolling volunteers. It was initially posted on April 12th 2022 and the last update occurred August 3rd of the same year. This trial has 53 slots at four hospitals expecting to be filled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

2022. "Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05074810.

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