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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCLA Hematology/Oncology
Santa Monica, California, United States
SCRI at HealthOne
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
START MidWest
Grand Rapids, Michigan, United States
NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York, United States
New York University Langone Health
New York, New York, United States
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, United States
US Oncology Investigational Products Center
Dallas, Texas, United States
Start Date
June 12, 2023
Primary Completion Date
January 1, 2026
Completion Date
June 1, 2026
Last Updated
November 18, 2025
126
ESTIMATED participants
TNG260
DRUG
Pembrolizumab
DRUG
Lead Sponsor
Tango Therapeutics, Inc.
NCT07486219
NCT07485114
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05198830