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

Description

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

Non Small Cell Lung Cancer, Solid Tumors, Adult, Endometrial Cancer, Pancreatic Cancer, Cervical Cancer, Breast Cancer, Carcinoma of Unknown Primary

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Santa Monica

UCLA Hematology/Oncology, Santa Monica, California, United States, 90404

Denver

SCRI at HealthOne, Denver, Colorado, United States, 80218

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

New York

New York University Langone Health, New York, New York, United States, 10016

Nashville

Sarah Cannon Tennessee Oncology, Nashville, Tennessee, United States, 37203

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Fairfax

NEXT Oncology Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tango Therapeutics, Inc.,

Adam Crystal, MD, PhD, STUDY_DIRECTOR, Tango Therapeutics, Inc.

Study Record Dates

2025-06