A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Start Date
3/5/2025
Completion Date
8/1/2029
Summary
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
Detailed Description
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 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ALTA3263
cetuximab
mFOLFOX6
Pembrolizumab
Pemetrexed + Cisplatin /Carboplatin
mFOLFIRINOX
GnP
Midazolam
Conditions
Locations
Research Site
Orlando, Florida 32827
United States
Research Site
Boston, Massachusetts 02114
United States
Research Site
Boston, Massachusetts 02115
United States
Research Site
St Louis, Missouri 63110
United States
Research Site
New York, New York 10016
United States
Research Site
New York, New York 10032
United States
Research Site
Durham, North Carolina 27710
United States
Research Site
Nashville, Tennessee 37203
United States
Research Site
Houston, Texas 77030
United States
Research Site #2
San Antonio, Texas 78229
United States
Research Site
San Antonio, Texas 78229
United States
Research Site
Fairfax, Virginia 22031
United States