Status:
TERMINATED
Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors
Lead Sponsor:
Tango Therapeutics, Inc.
Conditions:
Breast Cancer
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 H...
Detailed Description
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 eval...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06065059
Start Date
December 8 2023
End Date
May 22 2024
Last Update
August 13 2024
Active Locations (7)
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1
HealthONE
Denver, Colorado, United States, 80218
2
Mid Florida Cancer Centers
Orange City, Florida, United States, 32763
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215