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New pill targets Hard-to-Treat cancers with missing gene

NCT ID NCT05732831

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 2 times

Summary

This study tests an experimental drug called TNG462 for people with advanced solid tumors that have a specific genetic deletion (MTAP). The drug is taken by mouth and aims to slow or stop tumor growth. The trial has two parts: first, finding the safest dose, and then testing that dose in more patients with certain tumor types. Up to 225 adults with tumors that have not responded to standard treatments may join.

Why investors are watching

Tango Therapeutics runs this first-in-human study of TNG462, an oral PRMT5 inhibitor, in patients with advanced solid tumors that carry an MTAP deletion. The trial tests safety and early anti-tumor activity across dose escalation and dose expansion, so the readout gives the company its first human evidence for its lead approach. For a small public company, that evidence shapes whether the program can advance and whether partners or investors stay interested.

If it works: A positive result could support moving TNG462 into later-stage testing and draw partnership or financing interest in the MTAP-deleted tumor strategy. Early signs of anti-tumor activity in these tumor types would give the company a clinical foothold in a genetically defined patient group.

If it fails: Early-phase trials often fail on safety or show too little anti-tumor activity, and either outcome would set the program back. A delay or miss would leave a small company with fewer shots on goal and heavier reliance on outside funding.

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 225 people

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

Started

May 2023

Expected to finish

Jun 2028

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: 1. Age: ≥18 years-of-age at the time of signature of the main study ICF 2. Performance status: ECOG Performance Score of 0 to 1 3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor 4. Prior standard therapy, as available 5. Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by next- generation sequencing or absence of MTAP protein in a tumor detected by IHC. 6. Adequate organ function/reserve per local labs 7. Adequate liver function per local labs 8. Adequate renal function per local labs 9. Negative serum pregnancy test result at screening 10. Written informed consent must be obtained according to local guidelines Exclusion Criteria: 1. Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms 2. Uncontrolled intercurrent illness that will limit compliance with the study requirements 3. Active infection requiring systemic therapy 4. Currently participating in or has planned participation in a study of another investigational agent or device 5. Impairment of GI function or disease that may significantly alter the absorption of oral TNG462 6. Active prior or concurrent malignancy. 7. Central nervous system metastases associated with progressive neurological symptoms 8. Current active liver disease from any cause 9. Known to be HIV positive, unless all of the following criteria are met: 1. CD4+ count ≥300/μL 2. Undetectable viral load 3. Receiving highly active antiretroviral therapy 10. Clinically relevant cardiovascular disease 11. A female patient who is pregnant or lactating 12. Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions 13. Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the safety of the patient or impair the assessment of study results

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma mesothelioma neurofibrosarcoma sarcoma

As listed by the trial registrant

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

Locally advanced solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CHU de Brest

    RECRUITING

    Brest, 29200, France

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

  • Centre Berard Leon

    RECRUITING

    Lyon, 69373, France

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists & Research Institute

    COMPLETED

    Lake Mary, Florida, 32746, United States

  • Grand Valley Oncology

    RECRUITING

    Grand Junction, Colorado, 81505, United States

  • Henry Ford Cancer Center

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital HM Nou Delfos

    RECRUITING

    Barcelona, 08023, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital de Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • ICO l'Hospitalet - Hospital Duran i Reynals

    RECRUITING

    Barcelona, 08908, Spain

  • Institut de Cancerologie de l'Ouest - Hôpital Saint Herblain - PPDS

    RECRUITING

    Saint-Herblain, 44805, France

  • Institute Gustav Roussy

    RECRUITING

    Villejuif, 94805, France

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02214, United States

  • Midwestern Regional Medical Center, City of Hope Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • New York University Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Next Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Sarah Cannon Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University Chicago Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Vall d'Hebron Barcelona Hospital

    RECRUITING

    Barcelona, Catalonia, Spain

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