Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Tango Therapeutics, Inc.
Study ID
NCT06922591
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Lung Cancer
  • MTAP Deletion
  • NSCLC
  • PDAC
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Pancreatic Cancer Metastatic
  • RAS Mutation
  • Thoracic Cancer

Eligibility Criteria

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

Interventions

  • TNG462 — DRUG
    MTA cooperative PRMT5 inhibitor
  • RMC-9805 — DRUG
    RAS(ON) G12D selective covalent inhibitor
  • RMC-6236 — DRUG
    RAS(ON) multi-selective inhibitor
  • mFOLFIRINOX — DRUG
    Chemotherapy
  • gemcitabine/nab-paclitaxel — DRUG
    Chemotherapy

Study Details

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.

Key Dates

Start date
May 31, 2025
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Dose Escalation 1A
    Escalating oral doses of TNG462 in combination with oral RMC-6236
  • Experimental: Dose escalation 1B
    Escalating oral doses of TNG462 in combination with oral RMC-9805
  • Experimental: Dose Expansion 2A
    Expansion arm at the RDE(s) of oral TNG462 in combination with oral RMC-6236
  • Experimental: Dose Expansion 2B
    Expansion arm at the RDE(s) of oral TNG462 in combination with oralRMC-9805
  • Experimental: Experimental: Dose Escalation 1C
    Escalating doses of TNG462 in combination with mFOLFIRINOX
  • Experimental: Experimental: Dose Escalation 1D
    Escalating doses of TNG462 in combination with gemcitabine/nab-paclitaxel
  • Experimental: Experimental: Dose Expansion 2C
    Expansion arm at the RDE(s) of TNG462 in combination with mFOLFIRINOX
  • Experimental: Experimental: Dose Expansion 2D
    Expansion arm at the RDE(s) of TNG462 in combination with gemcitabine/nab-paclitaxel

Primary Outcome Measure

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

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Mayo Clinic ScottsdaleScottsdaleArizona85259-5452
Mitesh Borad, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute DenverDenverColorado80218
Gerald Falchook, MD, MS (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Marcus Noel, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Hani Babiker, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611-2908
Chengwei Peng, MD (PRINCIPAL_INVESTIGATOR)
University of IndianaIndianapolisIndiana46202
Anita Turk, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Health CareIowa CityIowa52242
Naomi Fei, MD, MS (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
Kimberly Perez, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Harshabad Singh, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Cancer CenterRochesterMinnesota55905-0001
Kaushal Parikh, MD (PRINCIPAL_INVESTIGATOR)
Nebraska Cancer SpecialistsOmahaNebraska68124
Joel Michalski, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York11065
Eileen O'Reilly, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Kristen Spencer, DO, MPH (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-7305
Shetal Patel, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Jordi Rodon Ahnert, MD (PRINCIPAL_INVESTIGATOR)
NEXT DallasIrvingTexas74039
Siraj Sen, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112
Vaia Florou, MD, MS (PRINCIPAL_INVESTIGATOR)
NEXT OncologyFairfaxVirginia22031
Alexander Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic Scottsdale· Scottsdale, AZSarah Cannon Research Institute Denver· Denver, COGeorgetown University Medical Center· Washington D.C., DCMayo Clinic Jacksonville· Jacksonville, FLNorthwestern Memorial Hospital· Chicago, ILUniversity of Indiana· Indianapolis, IN

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