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 is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and -expansion study designed to determine the MTD of TNG260 as single agent and in combination with pembrolizumab, to determine the RP2D(s) of the combination, and to evaluate the safety and tolerability, PK, and antineoplastic activity of escalating oral doses of TNG260 when administered alone and with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11-mutated solid tumors who have progressed on at least 1 line of standard therapy or are ineligible for standard therapies. In Phase 1 (dose escalation), at least 3 DLT-evaluable participants will be enrolled in sequentially escalating dose cohorts to determine the MTD of single agent TNG260, the MTD of the combination of TNG260 and pembrolizumab, and the RP2D(s) of TNG260 in combination with a standard dose of pembrolizumab. The dose escalation of TNG260 will be guided by two BLRMs based on any DLTs observed in the first cycle (ie, the first 21 days) of the single agent therapy and the second cycle for the combination therapy. Participants in Phase 2 (dose expansion) will be dosed at the RP2D(s) determined from Phase 1 based on demonstrated tolerability, together with available PK data and results of target engagement studied during Phase 1 (or other measures including PD and efficacy), as applicable. Three Phase 2 combination expansion arms (TNG260 in combination with pembrolizumab) will enroll up to approximately 30 participants each.
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