An official website of the United States government
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
Trial Status: active
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
Inclusion Criteria
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06162221.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not Available
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Approved
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Temporarily closed to accrual
Name Not Available
The platform study design allows combinations of RAS(ON) inhibitors with other anticancer
agents or as a monotherapy to be evaluated in patients with RAS-mutated solid tumors with
a focus on NSCLC.
This is an open-label platform Phase 1b/2 study to evaluate the safety, tolerability,
pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors
combined with Standard of Care (SOC), or as a monotherapy and to define the Recommended
Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with KRAS or RAS mutations will
be specified in each subprotocol.
Subprotocol A is an open-label, multicenter, Phase 1b/2 study of RMC-6291, with or
without RMC-6236, in combination with pembrolizumab, with or without chemotherapy, in
patients with KRAS G12C-mutated advanced solid tumors.
Subprotocol B is an open-label, multicenter, Phase1b/2 study of RMC-6236 in combination
with pembrolizumab, with or without chemotherapy, in patients with RAS-mutated non-small
cell lung cancer (NSCLC)
Subprotocol C is an open-label, multicenter, Phase1b/2 study of RMC-9805 with or without
RMC-6236, in combination with other anticancer agents, in patients with RAS G12D-mutated
non-small cell lung cancer (NSCLC)
Subprotocol D is a Phase 2, Open-label, Multicenter Study of Zoldonrasib (RMC-9805) in
Previously Treated Patients with RAS G12D-Mutant Non-Small Cell Lung Cancer (NSCLC)
Subprotocols A, B, and C consist of two parts: Part 1 - Dose Exploration and Part 2 -
Dose Expansion. Subprotocol D consists of only one part.
