Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05887492

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

Led by Tango Therapeutics, Inc. · Updated on 2025-11-18

126

Participants Needed

13

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Is 18 years of age or older at the time of signing consent
  • Has ECOG performance status of 0 or 1
  • Has measurable disease based on RECIST v1.1
  • Has documented STK11 mutation in a solid tumor verified by a validated test
  • Has confirmed diagnosis of locally advanced or metastatic solid tumor
  • Has adequate organ, liver, and renal function based on local lab tests
  • Has a negative serum pregnancy test at screening
  • Has provided written informed consent according to local guidelines
Not Eligible

You will not qualify if you...

  • Known allergy or intolerance to TNG260, PD-1 antibody, or their ingredients
  • Uncontrolled illness limiting study compliance
  • Active infection needing systemic therapy
  • Participating in or planning to participate in another investigational study
  • Gastrointestinal issues that could affect oral TNG260 absorption
  • Active prior or current other malignancy
  • CNS metastases with worsening neurological symptoms
  • Active liver disease
  • Clinically significant heart disease
  • Pregnant or breastfeeding female patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

UCLA Hematology/Oncology

Santa Monica, California, United States, 90404

Actively Recruiting

2

SCRI at HealthOne

Denver, Colorado, United States, 80218

Actively Recruiting

3

Florida Cancer Specialists

Sarasota, Florida, United States, 34232

Actively Recruiting

4

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

5

Henry Ford Health System

Detroit, Michigan, United States, 48202

Actively Recruiting

6

START MidWest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

7

NYU Langone Hematology Oncology Associates-Mineola

Mineola, New York, United States, 11501

Actively Recruiting

8

New York University Langone Health

New York, New York, United States, 10016

Actively Recruiting

9

Sarah Cannon Tennessee Oncology

Nashville, Tennessee, United States, 37203

Actively Recruiting

10

US Oncology Investigational Products Center

Dallas, Texas, United States, 75246

Actively Recruiting

11

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

12

NEXT Oncology Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

13

US Oncology Investigational Products Center

Norfolk, Virginia, United States, 23502

Actively Recruiting

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Research Team

A

Adam Crystal, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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