Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors
NCT06065059 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2024-08-13
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.
Conditions
- Breast Cancer
- Ovarian Cancer
- Pancreas Cancer
- Prostate Cancer
- BRCA1 Mutation
- BRCA-Mutated Ovarian Carcinoma
- BRCA-Associated Breast Carcinoma
- HRD Positive Advanced Ovarian Cancer
Interventions
- DRUG
-
TNG348
Ubiquitin Specific Peptidase 1 (USP1) inhibitor
- DRUG
-
PARP inhibitor
Sponsors & Collaborators
-
Tango Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Adam Crystal, MD, PhD · Tango Therapeutics, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-08
- Primary Completion
- 2024-05-22
- Completion
- 2024-05-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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