Trials / Recruiting
RecruitingNCT05887492
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
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
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- Sponsor
- Tango Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TNG260 | CoREST inhibitor, administered orally |
| DRUG | Pembrolizumab | Pembrolizumab, an anti-PD-1 antibody, administered intravenously |
Timeline
- Start date
- 2023-06-12
- Primary completion
- 2026-01-01
- Completion
- 2026-06-01
- First posted
- 2023-06-02
- Last updated
- 2025-11-18
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05887492. Inclusion in this directory is not an endorsement.