Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Non Small Cell Lung Cancer, Solid Tumors, Adult, Lung Cancer, Lung Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT05887492

Run by

Tango Therapeutics, Inc.

People needed

126

Starts

2023-06-12

Expected to finish

2026-09-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Written informed consent must be obtained according to local guidelines

You may not qualify if…

• Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its excipients
• Uncontrolled intercurrent illness that will limit compliance with the study requirements
• Active infection requiring systemic therapy
• Currently participating in or has planned participation in a study of another investigational agent or device
• Impairment of GI function or disease that may significantly alter the absorption of oral TNG260
• Active prior or concurrent malignancy.
• Central nervous system metastases associated with progressive neurological symptoms
• Current active liver disease from any cause
• Clinically relevant cardiovascular disease
• A female patient who is pregnant or lactating

Where it is running

• 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
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Oncology Virginia — Fairfax, Virginia, United States
• US Oncology Investigational Products Center — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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