Study of RAS(ON) Inhibitor Combinations 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 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
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)

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.
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