Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

About

Brief Summary

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other.

The first four subprotocols include the following:

Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Inclusion criteria:

All Patients (unless otherwise noted):

≥ 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 and Subprotocol D)

Exclusion criteria:

All Patients:

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