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
Recruiting
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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

Start date
Jun 12, 2023
Status verified
Jul 2025
Primary completion
Jan 31, 2026
Completion
Jun 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 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
UCLA Hematology/OncologySanta MonicaCalifornia90404
Jonathan Goldman, MD (PRINCIPAL_INVESTIGATOR)
SCRI at HealthOneDenverColorado80218
Gerald Falchook, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232
Judy Wang, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Mark Awad, MD, PhD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Shiresh Gadgeel, MD (PRINCIPAL_INVESTIGATOR)
START MidWestGrand RapidsMichigan49546
Manish Sharma, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Hematology Oncology Associates-MineolaMineolaNew York11501
Salman Punekar, MD (PRINCIPAL_INVESTIGATOR)
New York University Langone HealthNew YorkNew York10016
Salman Punekar, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Tennessee OncologyNashvilleTennessee37203
David Spigel, MD (PRINCIPAL_INVESTIGATOR)
US Oncology Investigational Products CenterDallasTexas75246
Kartik Konduri, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Ferdinandos Skoulidis, MD (PRINCIPAL_INVESTIGATOR)
NEXT Oncology VirginiaFairfaxVirginia22031
Alex Spira, MD (PRINCIPAL_INVESTIGATOR)
US Oncology Investigational Products CenterNorfolkVirginia23502
Jedrzej Wykretowicz, MD (PRINCIPAL_INVESTIGATOR)

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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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