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

Stopped early · Phase 1/Phase 2

Conditions studied: Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer, BRCA1 Mutation, BRCA-Mutated Ovarian Carcinoma, BRCA-Associated Breast Carcinoma, HRD Positive Advanced Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT06065059

Run by

Tango Therapeutics, Inc.

People needed

7

Starts

2023-12-08

Expected to finish

2024-05-22

Last updated by the study team

2024-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• HealthONE — Denver, Colorado, United States
• Mid Florida Cancer Centers — Orange City, Florida, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• New York University Langone Health — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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