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Not recruiting
Phase 1
Phase 2

TNG260 & Anti-PD Antibody

Sponsor:

Tango Therapeutics, Inc.

Code:

NCT05887492

Conditions

Non Small Cell Lung Cancer

Solid Tumors, Adult

Lung Cancer

Lung Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TNG260

Pembrolizumab

Study Details

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.

Conditions

Non Small Cell Lung Cancer

Solid Tumors, Adult

Lung Cancer

Lung Adenocarcinoma

Study ID

NCT05887492

Start date

Jun 12, 2023

Status verified date

Jul, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

126 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD

experimental: Dose Expansion in NSCLC with KRAS Mutation

Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab

experimental: Dose Expansion in NSCLC with KRAS Wild type

Participants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab

experimental: Dose Expansion in Advanced or Metastatic Solid Tumors

Participants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab

Interventions

TNG260

CoREST inhibitor, administered orally

Pembrolizumab

Pembrolizumab, an anti-PD-1 antibody, administered intravenously

Primary outcome measure

  • Determine the MTD and RP2D(s) (Phase 1 only) [ Time Frame: 42 days ]
  • Measure antitumor activity using RECIST 1.1 (Phase 2 only) [ Time Frame: 12 weeks ]

Central Contacts and Locations

More Information

Sponsor

Tango Therapeutics, Inc.

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • STK11
  • KRAS wild type
  • LKB1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by Tango Therapeutics, Inc. on 2026-07-06.