Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Tim Cloughesy, MD (ucla)

Description

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 192 participants.

Official Title

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

Details

This is a Phase 1/2 multi-center, open label study in solid tumor patients (including glioblastoma) 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, 6 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.

Keywords

Locally Advanced Solid Tumor, MTAP deletion, PRMT5, cholangiocarcinoma, NSCLC, mesothelioma, MPNST, Tango, Glioblastoma multiforme, pancreatic, GBM, sarcoma, Neoplasms, TNG908

Eligibility

You can join if…

Open to people ages 18 years and up

  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 or Karnofsky performance status score ≥70.
  3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor or for GBM, have R/R disease.
  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

You CAN'T join if...

  1. Known allergies, hypersensitivity, or intolerance to TNG908 or its excipients
  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 TNG908
  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
      1. Clinically relevant cardiovascular disease
      2. A female patient who is pregnant or lactating
      3. Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
        1. 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

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • The University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Lead Scientist at University of California Health

  • Tim Cloughesy, MD (ucla)
    Professor of Clinical, Neurology, Medicine. Authored (or co-authored) 420 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tango Therapeutics, Inc.
ID
NCT05275478
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 192 study participants
Last Updated