Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
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
Tango Therapeutics, Inc.
225 participants
May 26, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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 Criteria16
- 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
Interventions
TNG462, a selective PRMT5 inhibitor, will be administered orally
An anti PD-1 antibody, will be administered intravenously
Locations(26)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05732831