Ovarian Cancer Clinical Trial
Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors
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.
Full 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 evaluate the safety, tolerability, and preliminary antitumor activity of TNG348 single agent and in combination with olaparib in participants with BRCA1/2 mutant or other HRD+ advanced or metastatic solid tumors.
In Phase 1 (dose escalation), the single agent component will explore escalating oral doses of TNG348 administered alone and in combination with olaparib.
Participants in Phase 2 (dose expansion) will be dosed at the RP2D(s) determined from Phase 1 based on safety and tolerability demonstrated, along with the available PK data and studied during Phase 1, as applicable.
In the Phase 2 portion of the study, both single agent and combination therapy may be evaluated to assess an early signal of clinical benefit, as well as for confirmation of safety and tolerability.
Eligibility 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
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There are 6 Locations for this study
Denver Colorado, 80218, United States More Info
Principal Investigator
Orange City Florida, 32763, United States More Info
Principal Investigator
Sarasota Florida, 34232, United States More Info
Principal Investigator
Boston Massachusetts, 02215, United States More Info
Principal Investigator
New York New York, 10016, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
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