Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumors, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| TNG260 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD
- interventionNames
- Drug: TNG260
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Dose Expansion in NSCLC with KRAS Mutation
- description
- Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab
- interventionNames
- Drug: TNG260
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 measurable disease based on RECIST v1.1. * All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytical method * Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor. * Adequate organ function/reserve per local labs * Adequate liver function per local labs * Adequate renal 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 TNG260, PD-1 antibody or its excipients * Uncontrolled intercurrent illness that will limit compliance with the study requirements * Active infection requiring systemic therapy * 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 oral TNG260 * Active prior or concurrent malignancy. * Central nervous system metastases associated with progressive neurological symptoms * Current active liver disease from any cause * Clinically relevant cardiovascular disease * A female patient who is pregnant or lactating
References
Publications (0)
Data not yet available