Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-29 @ 12:17 AM
Study NCT ID:
NCT05887492
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2023-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
Sponsor:
Tango Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.
The main question\[s\] it aims to answer are:
* the recommended dose for Phase 2
* to evaluate the safety and tolerability of the combination therapy
* to determine the pharmacokinetics of TNG260
* to evaluate the initial antineoplastic activity
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:
* the recommended dose for Phase 2
* to evaluate the safety and tolerability of the combination therapy
* to determine the pharmacokinetics of TNG260
* to evaluate the initial antineoplastic activity
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, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of TNG260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid tumors.
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?: