Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05887492
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-04-18
Brief Title:
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
Sponsor:
Tango Therapeutics Inc
Organization:
Tango Therapeutics Inc
Study Overview
Official Title:
A Phase 12 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:
2024-08
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 questions 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 questions 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 12 open-label multicenter dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 doses 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:
None
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?:
None