Phase 12 Study to Assess Safety and Early Effectiveness of Oral TNG456 Alone and With Abemaciclib in Adults With Solid Tumors Having MTAP Loss

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early antitumor effects of TNG456 alone and combined with abemaciclib in patients with advanced or metastatic solid tumors that have a confirmed MTAP loss. This is a Phase 12, multi-center, open-label study that includes a dose escalation phase and a dose expansion phase focusing on specific tumor types. The study plans to enroll up to 191 participants to better understand treatment options for these tumor conditions. The study involves two main parts an initial dose escalation phase where solid tumor patients receive increasing doses of oral TNG456 alone or with oral abemaciclib to find the maximum tolerated dose, followed by a dose expansion phase where six groups of patients with confirmed MTAP loss in various tumor types receive TNG456 alone or in combination at the recommended dose. Participants who tolerate treatment may continue until their disease progresses. During the trial, participants will undergo regular assessments including monitoring for side effects, measuring tumor response using RECIST v1.1 or RANO 2.0 criteria, and tracking drug levels in the body. The primary outcomes include determining the maximum tolerated dose in Phase 1 and assessing antitumor activity over 18 weeks in Phase 2. Safety and drug concentration will be closely observed throughout the study. Participation may last until disease progression or other study endpoints are reached.

Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss