Phase 12 Study of Oral TNG462 Combined With Other Treatments in Patients With Pancreatic or Non-Small Cell Lung Cancer Having MTAP Loss and RAS Mutation

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-cancer effects of the oral drug TNG462 in combination with other treatments in patients with pancreatic ductal adenocarcinoma PDAC or non-small cell lung cancer NSCLC who have specific genetic changes. This Phase 12 open-label study focuses on patients with MTAP loss, and for some groups, RAS mutations, aiming to find suitable dose levels and assess early treatment effects. The study includes multiple groups receiving escalating doses of TNG462 combined with either oral RMC-6236, oral RMC-9805, chemotherapy regimens mFOLFIRINOX, or gemcitabinenab-paclitaxel. The trial has two parts a dose escalation phase to find the maximum tolerated or recommended doses, followed by a dose expansion phase to further evaluate treatment combinations. Each treatment arm is designed to test safety and anti-cancer activity in these combinations. Participants will undergo regular monitoring for side effects, drug levels in the body, and cancer response over specified periods. Primary outcomes include determining the maximum tolerated dose in the dose escalation phase and evaluating anti-cancer activity after 12 weeks in the dose expansion phase. This involves assessments like tumor measurements based on RECIST criteria, lab tests, and vital signs. The study is expected to continue until late 2027, with ongoing safety and effectiveness evaluations throughout.

Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients