Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
ConditionLocally Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTango Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- TNG462
- Pembrolizumab
Treatment groups
225 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov