Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tango Therapeutics, Inc.
• Treatments: Olaparib

Criteria

Inclusion Criteria:

• Is ≥18 years of age at the time of signature of the main study ICF.

• Has ECOG performance status of 0 or 1.

• Has advanced or metastatic solid tumor with measurable disease based on RECIST v1.1.

• All participants must have documented BRCA 1/2 mutant or other HRD+ in solid tumor, which is identified through a validated sequencing test

• Adequate organ and bone marrow 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 TNG348, olaparib or its excipients

• Uncontrolled intercurrent illness that will limit compliance with the study requirements

• 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 study drug

• Active prior or concurrent malignancy.

• Central nervous system metastases associated with progressive neurological symptoms

• Participant with MDS

• Clinically relevant cardiovascular disease

• Participant with known active or chronic infection

• A female patient who is pregnant or lactating