3263-001: A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
Trial Description
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in
adults with advanced solid tumors with KRAS mutations.
Eligibility Requirements
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.