Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

Part of paid clinical trials in Santa Monica, California.

Sponsor
Tango Therapeutics, Inc.
Study ID
NCT05887492
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TNG260 — DRUG
    CoREST inhibitor, administered orally
  • Pembrolizumab — DRUG
    Pembrolizumab, an anti-PD-1 antibody, administered intravenously

Study Details

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.

Key Dates

First listed
Jun 2, 2023
Start date
Jun 12, 2023
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
126 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Determine the MTD and RP2D(s) (Phase 1 only) [ Time Frame: 42 days ]

Locations (13)

FacilityCityStateZIPSite coordinators
UCLA Hematology/OncologySanta MonicaCalifornia90404-
SCRI at HealthOneDenverColorado80218-
Florida Cancer SpecialistsSarasotaFlorida34232-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford Health SystemDetroitMichigan48202-
START MidWestGrand RapidsMichigan49546-
NYU Langone Hematology Oncology Associates-MineolaMineolaNew York11501-
New York University Langone HealthNew YorkNew York10016-
Sarah Cannon Tennessee OncologyNashvilleTennessee37203-
US Oncology Investigational Products CenterDallasTexas75246-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
NEXT Oncology VirginiaFairfaxVirginia22031-
US Oncology Investigational Products CenterNorfolkVirginia23502-

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UCLA Hematology/Oncology· Santa Monica, CASCRI at HealthOne· Denver, COFlorida Cancer Specialists· Sarasota, FLDana Farber Cancer Institute· Boston, MAHenry Ford Health System· Detroit, MISTART MidWest· Grand Rapids, MI

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