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Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
Trial Status: active
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.
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 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 Criteria
Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms
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 TNG462
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
Additional locations may be listed on ClinicalTrials.gov for NCT05732831.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Name Not Available
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Temporarily closed to accrual
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not Available
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.
