Status:
ACTIVE_NOT_RECRUITING
Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors
Lead Sponsor:
Tango Therapeutics, Inc.
Conditions:
Locally Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Detailed Description
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 escalati...
Eligibility Criteria
Inclusion
- Age: ≥18 years-of-age at the time of signature of the main study ICF
- Performance status: ECOG Performance Score of 0 to 1 or Karnofsky performance status score ≥70.
- Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor or for GBM, have R/R disease.
- Prior standard therapy, as available
- 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.
- 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
- 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
- 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
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05275478
Start Date
March 23 2022
End Date
December 1 2025
Last Update
November 14 2025
Active Locations (20)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
University of California San Francisco
San Francisco, California, United States, 94143
3
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
4
Grand Valley Oncology
Grand Junction, Colorado, United States, 81505