Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors

  • STATUS
    Recruiting
  • End date
    Sep 16, 2025
  • participants needed
    170
  • sponsor
    Tango Therapeutics, Inc.
Updated on 16 June 2022

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, TNG908, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 170 participants.

Description

This is a Phase 1/2 multi-center, open label study in solid tumor patients (excluding gliomas) who have a confirmed homozygous MTAP deletion in their tumor. The Phase 1 portion is a dose escalation study of oral TNG908 in patients with confirmed MTAP-deleted solid tumors. In Phase 2, 5 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D of TNG908. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Details
Condition Locally Advanced Solid Tumor
Treatment TNG908
Clinical Study IdentifierNCT05275478
SponsorTango Therapeutics, Inc.
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: ≥18 years-of-age at the time of signature of the main study ICF
Performance status: ECOG Performance Score of 0 to 1
Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
Prior standard therapy, as available
Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by nextgeneration sequencing
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
Patient must be able to swallow tablets
Written informed consent must be obtained according to local guidelines

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to TNG908 or its excipients
Uncontrolled intercurrent illness that will limit compliance with the study requirements
Active infection requiring systemic therapy
Diagnosis of malignant glioma
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 TNG908
Active prior or concurrent malignancy
Central nervous system metastases associated with progressive neurological symptoms
Current active liver disease from any cause
Known to be HIV positive, unless all of the following criteria are met
CD4+ count ≥300/μL
Undetectable viral load
Receiving highly active antiretroviral therapy
Clinically relevant cardiovascular disease
A female patient who is pregnant or lactating
Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
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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