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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-01-01

Brief Summary

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This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.

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Detailed Description

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This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with KRAS G12C mutant NSCLC who have been exposed to prior G12C inhibitor and experienced progressive disease.

Conditions

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Non Small Cell Lung Cancer KRAS Activating Mutation Advanced Cancer Metastatic Cancer Malignant Neoplasm of Lung Malignant Neoplastic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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avutometinib(VS-6766)+adagrasib

To determine the recommended phase 2 dose (RP2D) for VS-6766 in combination with adagrasib in G12C inhibitor exposed patients

Group Type EXPERIMENTAL

avutometinib (VS-6766) and adagrasib

Intervention Type DRUG

The RP2D of VS-6766 + adagrasib determined in Part A will be used in Part B dose expansion

avutometinib (VS-6766)+adagrasib RP2D

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

Group Type EXPERIMENTAL

avutometinib (VS-6766) and adagrasib

Intervention Type DRUG

The RP2D of VS-6766 + adagrasib determined in Part A will be used in Part B dose expansion

Interventions

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avutometinib (VS-6766) and adagrasib

The RP2D of VS-6766 + adagrasib determined in Part A will be used in Part B dose expansion

Intervention Type DRUG

Other Intervention Names

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KRAS G12C Inhibitor, adagrasib, KRAZATI®

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects ≥ 18 years of age
* Histologic or cytologic evidence of NSCLC
* Known KRAS G12C mutation
* The subject must have received prior therapy with a KRAS G12C inhibitor and experienced progression
* Must have received appropriate treatment with at least one prior systemic regimen, but no more than 3 prior regimens, for Stage 3B-C or 4 NSCLC
* Measurable disease according to RECIST 1.1
* An Eastern Cooperative Group (ECOG) performance status ≤ 1
* Adequate organ function
* Adequate recovery from toxicities related to prior treatments
* Agreement to use highly effective method of contraceptive

Exclusion Criteria

* Prior chemotherapy, targeted therapies, radiotherapy, immunotherapy or treatment with an investigational agent within 14 days of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C and chest radiation; within 6 months prior to Cycle 1 Day 1 for chest radiation \> 30Gy)
* History of prior malignancy, with the exception of curatively treated malignancies
* Major surgery within 4 weeks (excluding placement of vascular access)
* Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
* Exposure to strong inhibitors of breast cancer resistance protein (BCRP) within 14 days prior to the first dose and during the course of therapy
* Symptomatic brain metastases requiring steroids or other local interventions within the 2 weeks prior to initiation of therapy
* Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
* Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
* Active skin disorder that has required systemic therapy within the past 1 year
* History of rhabdomyolysis or interstitial lung disease
* Concurrent ocular disorders
* Concurrent heart disease or severe obstructive pulmonary disease
* Subjects with the inability to swallow oral medications

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No