The goal of this interventional clinical trial is to learn about TNG348, a ubiquitin
specific peptidase 1 (USP1) inhibitor, alone and in combination with olaparib in patients
with BRCA 1/2 mutant or HRD+ solid tumors.
The main question[s] it aims to answer are:
- to evaluate the safety and tolerability of single agent and combination therapy
- to determine the recommended dose for Phase 2 of single agent and combination
therapy
- to determine the pharmacokinetics of TNG348 as a single agent and in combination
therapy
- to evaluate the initial antineoplastic activity as a single agent and in combination
therapy
Participants will receive study treatment until they experience an undesirable side
effect, their disease progresses or until they withdraw consent.
Additional locations may be listed on ClinicalTrials.gov for NCT06065059.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Name Not Available
This is a first-in-human Phase 1/2, open-label, multi-center, dose-escalation and
expansion study designed to determine the maximum-tolerated dose (MTD) and recommended
Phase 2 dose(s) (RP2D) and evaluate the safety, tolerability, and preliminary antitumor
activity of TNG348 single agent and in combination with olaparib in participants with
BRCA1/2 mutant or other HRD+ advanced or metastatic solid tumors.
In Phase 1 (dose escalation), the single agent component will explore escalating oral
doses of TNG348 administered alone and in combination with olaparib.
Participants in Phase 2 (dose expansion) will be dosed at the RP2D(s) determined from
Phase 1 based on safety and tolerability demonstrated, along with the available PK data
and studied during Phase 1, as applicable.
In the Phase 2 portion of the study, both single agent and combination therapy may be
evaluated to assess an early signal of clinical benefit, as well as for confirmation of
safety and tolerability.
Lead OrganizationTango Therapeutics
Principal InvestigatorAdam Crystal
