RecruitingPhase 1NCT06835569
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
Sponsor
Alterome Therapeutics, Inc.
Enrollment
188 participants
Start Date
Mar 5, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria2
- 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.
Interventions
DRUGALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
DRUGcetuximab
Cetuximab injection for IV use will be administered at a protocol-defined dose
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06835569
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