Study of RAS(ON) Inhibitor Combinations in Patients with Advanced RAS-mutated NSCLC

Description

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with each other. The first three subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC

Conditions

Non-Small Cell Lung Cancer, NSCLC, KRAS, NRAS, HRAS-mutated NSCLC, KRAS G12C-mutated Solid Tumors, Lung Cancer, Lung Cancer Stage IV, Advanced Solid Tumor, Cancer, RAS G12D-mutated NSCLC

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Study Overview

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Study Details

Study overview

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with each other. The first three subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC

A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)

Study of RAS(ON) Inhibitor Combinations in Patients with Advanced RAS-mutated NSCLC

Condition
Non-Small Cell Lung Cancer, NSCLC
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope - Duarte, Duarte, California, United States, 91010

Irvine

City of Hope - Lennar, Irvine, California, United States, 92618

Sacramento

UC Davis, Davis Comprehensive Cancer Center, Sacramento, California, United States, 95817

San Francisco

UCSF Medical Center - Mission Bay, San Francisco, California, United States, 94158

Stanford

Stanford University, Stanford, California, United States, 94305

Washington

Georgetown University Medical Center, Washington, District of Columbia, United States, 20007

Plantation

Boca Raton Clinical Research Associates, Plantation, Florida, United States, 33322

St Augustine

Cancer Specialists of North Florida, St Augustine, Florida, United States, 32086

Detroit

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion), Detroit, Michigan, United States, 48202

Billings

Intermountain Health - St. Vincent Frontier Cancer Center, Billings, Montana, United States, 59102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥ 18 years of age
  • * ECOG PS is 0 to 1
  • * Adequate organ function as outlined by the study
  • * Received prior standard therapy appropriate for tumor type and stage
  • * Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)
  • * Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)
  • * Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C)
  • * Primary central nervous system (CNS) tumors
  • * Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
  • * Major surgery \< 28 days of first dose
  • * Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Revolution Medicines, Inc.,

Revolution Medicines, STUDY_DIRECTOR, Revolution Medicines

Study Record Dates

2028-12