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

ID#: NCT06162221

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: January 18, 2024

End Date: December 01, 2028

Contact Information:
Revolution Medicines
1-844-2-REVMED
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
Eligibility:

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 Other inclusion/exclusion criteria may apply.