Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Tango Therapeutics, Inc.
Study ID
NCT06810544
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • TNG456 — DRUG
    A selective PRMT5 inhibitor
  • abemaciclib — DRUG
    A kinase inhibitor

Study Details

This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 participants.

Key Dates

Start date
Mar 24, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: Single Agent and Combination Dose Escalation
    Solid tumor participants with confirmed MTAP loss will receive escalating doses of TNG456 single agent and in combination with abemaciclib to estimate the MTD
  • Experimental: NSCLC Single Agent Dose Expansion
    NSCLC (squamous and non squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s)
  • Experimental: GBM Single Agent Dose Expansion
    GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s)
  • Experimental: Tumor Agnostic Single Agent Dose Expansion
    Patients with specific solid tumor types that have a confirmed MTAP loss will receive TNG456 at the identified RP2D(s)
  • Experimental: NSCLC Combination Expansion
    NSCLC (squamous and non-squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib
  • Experimental: GBM Combination Expansion
    GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib
  • Experimental: Tumor Agnostic Combination Expansion
    Participants with specific tumor types with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib

Primary Outcome Measure

Phase 1 Maximum Tolerated Dose [ Time Frame: 21 days ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Mayo Clinic ScottsdaleScottsdaleArizona85259-5452
Mitesh Borad, MD (PRINCIPAL_INVESTIGATOR)
University of California, IrvineIrvineCalifornia92686
Cathleen Park, MD (PRINCIPAL_INVESTIGATOR)
University of California Los AngelesLos AngelesCalifornia90995
Timothy Cloughesy, MD (PRINCIPAL_INVESTIGATOR)
University of California at San FranciscoSan FranciscoCalifornia94143-2202
Nicolas Butowski, MD (PRINCIPAL_INVESTIGATOR)
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Solmaz Sahebjam, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Hani Babiker, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611-2908
Ditte Primdahl, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Jia Luo, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Cancer CenterRochesterMinnesota55905-0001
Kaushal Parikh, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York11065
Lauren Schaff, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Salman Punekar, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Dwight Owen, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Jordi Rodon, MD (PRINCIPAL_INVESTIGATOR)
University of Utah, Huntsman Cancer InstituteSalt Lake CityUtah84112-5500
Howard Coleman, MD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Alexander Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)

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