A Phase 1/2 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination with an anti-PD-1 Antibody in Patients with STK11-Mutated Advanced Solid Tumors

Brief description of study

This study is testing a new drug called TNG260 (a specific medicine referred to as a CoreDAC inhibitor that can undo the way the immune system is blocked when STK11 is not working properly; when used with a-PD1, it can make tumors shrink in STK11 mutated preclinical modesls) in people with advanced or spreading solid tumors that have a specific genetic change (STK11). The study has two parts: In the first part, researchers will determine the right amount of TNG260 to use to treat tumors, both by itself and with another drug called pembrolizumab. In the second part, researchers will give TNG260 at the beneficial dose of treating tumors to more individuals with various types of solid tumors. Investigators will watch the participants for a while to see if the treatment is safe and works well. If it helps, participants may continue getting the treatment with approval.


Clinical Study Identifier: s22-01128
Principal Investigator: Salman Rafi Punekar.
Other Investigators: Barbara Crump, Samantha VanMaanen, Jessica Wang, Elaine Shum, Sally Lau, Christy Lynn Spalink, Joshua K Sabari, David Mendoza, Melissa L Martinez, Vamsidhar Velcheti, Natalia Cherkassky.


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