Phase 1/2 Multi-Center Open-Label Study to Evaluate the Safety Tolerability and Preliminary Anti-tumor Activity of TNG462 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors

Brief description of study

A study called TNG462-C101 is being conducted to test a new medicine called TNG462 on patients with advanced or metastatic solid tumors who have a genetic alteration known as MTAP loss or MTAP deletion. The study has two parts: Phase 1 and Phase 2. In Phase 1, different doses through dose escalation (the process of gradually increasing the amount or strength of a medication given to a patient over time) of TNG462 will be given every day, and the positive effects and any side effects of TNG462 will be closely monitored. The dose will be increased slowly based on the results from previous patients.

In Phase 2, the selected dose from Phase 1 will be tested on more patients in a dose expansion (when a selected dose of a medication, previously chosen in a dose-escalation phase, is further tested on a larger group of patients) phase to see if it works well. The study will also check how the body processes the medicine and how it affects the tumors. Before patients can join the study, they will be checked to see if they have certain genetic changes related to their tumors that may affect results. The study will collect samples and do tests to make sure the medicine is safe and accepted by patients. If patients have any side effects, their dose may be changed.


Clinical Study Identifier: s23-00360
Principal Investigator: Salman Rafi Punekar.
Other Investigators: Nila Theresa De La Rosa, Scot Niglio, Samantha VanMaanen, Jessica Wang, Elaine Shum, Kristen Spencer, Joshua K Sabari, Keriann M Scavone, Kathleen M Madden, Nancy Chan, Caitlin Elizabeth Ryan, Douglas K Marks, Janice Mehnert, Nina Beri.


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