Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 3:45 PM
Study NCT ID:
NCT06065059
Status:
TERMINATED
Last Update Posted:
2024-08-13
First Post:
2023-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors
Sponsor:
Tango Therapeutics, Inc.
Organization:
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: