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NCT05732831 | RECRUITING | Locally Advanced Solid Tumor

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
Sponsor:

Tango Therapeutics, Inc.

Brief Summary:

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Condition or disease

Locally Advanced Solid Tumor

Intervention/treatment

TNG462

Pembrolizumab

Phase

PHASE1

PHASE2

Detailed Description:

This is a Phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed homozygous MTAP deletion in their tumor. The Phase 1 portion is a dose escalation study of oral TNG462 administered as a single agent and in combination with pembrolizumab in patients with confirmed MTAP-deleted solid tumors. In Phase 2, 6 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D(s) of TNG462 and in combination. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Study Type : INTERVENTIONAL
Estimated Enrollment : 225 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
Actual Study Start Date : 2023-05-26
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Location Details

NCT05732831

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94304

RECRUITING

United States, Colorado

Grand Valley Oncology

Grand Junction, Colorado, United States, 81505

RECRUITING

United States, Florida

Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Illinois

University Chicago Medicine

Chicago, Illinois, United States, 60637

RECRUITING

United States, Illinois

Carle Cancer Center

Urbana, Illinois, United States, 61801

RECRUITING

United States, Illinois

Midwestern Regional Medical Center, City of Hope Chicago

Zion, Illinois, United States, 60099

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02214

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Henry Ford Cancer Center

Detroit, Road cancer, United States, 48202

RECRUITING

United States, New York

New York University Langone Health

New York, New York, United States, 10016

RECRUITING

United States, Tennessee

Sarah Cannon Tennessee Oncology

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Utah

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

RECRUITING

United States, Virginia

Next Oncology Virginia

Fairfax, Virginia, United States, 22031

RECRUITING

France,

chu's B rest

Brest, France, 29200

RECRUITING

France,

Berard Leon Center

Lyon, France, 69373

RECRUITING

France,

Institute Gustav Roussy

Villejuif, France, 94805

RECRUITING

Spain, Catalonia

Vall d'Hebron Barcelona Hospital

Barcelona, Catalonia, Spain,

RECRUITING

Spain,

HM Nou Delphi Hospital

Barcelona, Spain, 08023

RECRUITING

Spain,

ICO L'Hospitalet - Hospital Duran i Reynals

Barcelona, Spain, 08908

RECRUITING

Spain,

Jimenez Diaz Foundation University Hospital

Madrid, Spain, 28040

RECRUITING

Spain,

Sanchinarro Hospital

Madrid, Spain, 28050

RECRUITING

Spain,

Virgen de la Victoria University Hospital

Málaga, Spain, 29010

RECRUITING

Spain,

Virgen del Rocio University Hospital

Sevilla, Spain, 41013