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A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Trial Status: active
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in
adults with advanced solid tumors with KRAS mutations.
Inclusion Criteria
Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
Unresectable or metastatic disease.
Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function
Exclusion Criteria
Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol
Known condition that prohibits the ability to swallow or absorb an oral medication. Other inclusion/exclusion criteria may apply.
Additional locations may be listed on ClinicalTrials.gov for NCT06835569.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable
KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults
with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the
safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of
ALTA3263, and aims to find the best dose. The study consists of two parts: Part 1 - Dose