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New hope for hard-to-treat cancers: experimental combo targets STK11 mutation

NCT ID NCT05887492

Disease control Sponsor: Tango Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests an experimental drug called TNG260 combined with an immunotherapy (pembrolizumab) in people with advanced solid tumors that have a specific gene change (STK11 mutation). The goal is to find the best dose and see if the combination is safe and can shrink tumors. About 126 adults with advanced lung or other solid tumors will take part.

Why investors are watching

Tango Therapeutics is testing TNG260, a CoREST inhibitor, combined with the immunotherapy pembrolizumab in patients with advanced solid tumors that carry an STK11 mutation. This mutation often makes tumors resistant to standard immunotherapy, so a drug that could restore sensitivity would address a clear unmet need. For a small company like Tango, this early-stage readout on safety, dosing, and initial tumor response is a major value driver.

If it works: If the combination shows acceptable safety and signs of tumor shrinkage or disease control, Tango could advance to a larger Phase 2 study and potentially position TNG260 as a new option for a genetically defined patient group. That would validate the company's approach and support further development.

If it fails: Early-phase trials often fail because the drug is unsafe, poorly tolerated, or shows no clear benefit. A negative or unclear result could delay the program, increase cash burn, and hurt the company's prospects, since Tango's value depends heavily on this asset.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung lung adenocarcinoma lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung adenocarcinoma Lung cancer Non-small cell lung cancer Solid tumors, adult

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34232, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031, United States

  • NYU Langone Hematology Oncology Associates-Mineola

    Mineola, New York, 11501, United States

  • New York University Langone Health

    New York, New York, 10016, United States

  • SCRI at HealthOne

    Denver, Colorado, 80218, United States

  • START MidWest

    Grand Rapids, Michigan, 49546, United States

  • Sarah Cannon Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Hematology/Oncology

    Santa Monica, California, 90404, United States

  • US Oncology Investigational Products Center

    Dallas, Texas, 75246, United States

  • US Oncology Investigational Products Center

    Norfolk, Virginia, 23502, United States

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Other studies related to the condition(s) this trial covers.