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Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

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Revolution Medicines

Status and phase

Active, not recruiting
Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: RMC-4630
Drug: Sotorasib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05054725
RMC-4630-03

Details and patient eligibility

About

The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC

Full description

This is a phase 2 multicenter, open-label study evaluating the efficacy, safety, tolerability, and pharmacokinetics (PK) of RMC-4630 in combination with sotorasib in subjects with KRASG12C mutant NSCLC after failure of prior standard therapies.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Subject must be ≥18 years of age.
  • Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed)

Exclusion Criteria

  • Primary central nervous system (CNS) tumors
  • Known or suspected leptomeningeal or brain metastases or spinal cord compression
  • Clinically significant cardiac disease
  • Known impairment of GI function that would alter the absorption
  • Active autoimmune disease requiring systemic treatment within past 2 years
  • History of severe allergic reactions to any of the study intervention components
  • Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
  • Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

47 participants in 2 patient groups

RMC-4630 and sotorasib, Safety Run-in
Experimental group
Description:
Safety Run-In: RMC-4630 and sotorasib
Treatment:
Drug: Sotorasib
Drug: RMC-4630
RMC-4630 and sotorasib, Expansion
Experimental group
Description:
Dose Expansion: RMC-4630 and sotorasib
Treatment:
Drug: Sotorasib
Drug: RMC-4630

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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