NCT06065059TerminatedPhase 1/2
Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors
Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG348 Single Agent and in Combination With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or Other HRD+ Solid Tumors
Source: ClinicalTrials.gov · Last updated 13 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 15 Sept 2023
- Start date
- 8 Dec 2023
- Primary completion date
- 22 May 2024
- Lead sponsor
- Tango Therapeutics, Inc.
- Diseases
- Ovarian cancer, Pancreatic cancer, Prostate cancer
- NCT number
- NCT06065059
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in or has planned participation in a study of another investigational agent or device
- Active prior or concurrent malignancy.
Other illness
- Known allergies, hypersensitivity, or intolerance to TNG348, olaparib or its excipients
- Uncontrolled intercurrent illness that will limit compliance with the study requirements
- Impairment of GI function or disease that may significantly alter the absorption of study drug
- Clinically relevant cardiovascular disease
- Participant with known active or chronic infection
Other
- Central nervous system metastases associated with progressive neurological symptoms
- Participant with MDS
- A female patient who is pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | United States | Unknown status |
| HealthONE | Denver | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center | Houston | United States | Unknown status |
| New York University Langone Health | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center | New York | United States | Unknown status |
| Mid Florida Cancer Centers | Orange City | United States | Unknown status |
| Florida Cancer Specialists | Sarasota | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.