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

Last updated: April 8, 2025
Sponsor: Tango Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cervical Cancer

Breast Cancer

Pelvic Cancer

Treatment

TNG260

Pembrolizumab

Clinical Study ID

NCT05887492
TNG260-C101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 isidentified through a validated analytical method

  • Has confirmed histologic or cytologic diagnosis of a locally advanced or metastaticsolid 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

Exclusion

Exclusion Criteria:

  • Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or itsexcipients

  • Uncontrolled intercurrent illness that will limit compliance with the studyrequirements

  • Active infection requiring systemic therapy

  • Currently participating in or has planned participation in a study of anotherinvestigational agent or device

  • Impairment of GI function or disease that may significantly alter the absorption oforal 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

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: TNG260
Phase: 1/2
Study Start date:
June 12, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • UCLA Hematology/Oncology

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • SCRI at HealthOne

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • START MidWest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • New York University Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Sarah Cannon Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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