Phase 11b Study of ALTA3263 for Adults With Advanced Solid Tumors Having KRAS Mutations

What this Trial Is About

Researchers are studying ALTA3263, an oral drug designed to inhibit multiple mutant forms of KRAS, in adults with advanced solid tumors that have KRAS mutations. This open-label Phase 11b study aims to assess the safety, tolerability, pharmacokinetics, and early clinical effects of ALTA3263 alone and in combination with other cancer treatments. The trial targets adults with unresectable or metastatic tumors who have progressed on or cannot tolerate standard therapies. Participants receive ALTA3263 continuously at doses defined by their assigned group. The study includes multiple treatment groups where ALTA3263 is given alone or combined with cetuximab, chemotherapy regimens such as mFOLFOX6, mFOLFIRINOX, gemcitabine with albumin-bound paclitaxel, pembrolizumab, and other combinations. A dose escalation phase is followed by a dose expansion phase to evaluate these regimens. Dosing schedules are protocol-defined for each cohort. During the study, participants are monitored for adverse events and dose-limiting toxicities over up to 39 months. Blood samples are collected to study drug levels and metabolism during treatment cycles lasting 21 days each. Researchers also measure tumor response, progression-free survival, and overall survival. Safety and tolerability are closely evaluated with regular assessments throughout the trial duration, which is expected to complete by August 2029.

A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations