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
Tango Therapeutics, Inc.
Summary
The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation. The main question\[s\] it aims to answer are: * the recommended dose for Phase 2 * to evaluate the safety and tolerability of the combination therapy * to determine the pharmacokinetics of TNG260 * to evaluate the initial antineoplastic activity Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.
Description
This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of TNG260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Is ≥18 years of age at the time of signature of the main study ICF. * Has ECOG performance status of 0 or 1. * Has measurable disease based on RECIST v1.1. * All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytical method * Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor. * Adequate organ function/reserve per local labs * Adequate liver function per local labs * Adequate renal function per local labs * Negative serum pregnancy test result at screening * Writte…
Interventions
- DrugTNG260
CoREST inhibitor, administered orally
- DrugPembrolizumab
Pembrolizumab, an anti-PD-1 antibody, administered intravenously
Locations (13)
- UCLA Hematology/OncologySanta Monica, California
- SCRI at HealthOneDenver, Colorado
- Florida Cancer SpecialistsSarasota, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- Henry Ford Health SystemDetroit, Michigan
- START MidWestGrand Rapids, Michigan