Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Part of paid clinical trials in Palo Alto, California.

Sponsor
Tango Therapeutics, Inc.
Study ID
NCT05732831
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • TNG462 — DRUG
    TNG462, a selective PRMT5 inhibitor, will be administered orally
  • Pembrolizumab — DRUG
    An anti PD-1 antibody, will be administered intravenously

Study Details

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Key Dates

Start date
May 26, 2023
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: Dose Escalation
    Participants with MTAP-deleted solid tumors (excluding primary CNS) will receive escalating doses of TNG462 single agent and in combination with pembrolizumab to estimate the MTD
  • Experimental: Dose Expansion in NSCLC
    Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG462 at the identified RP2D(s)
  • Experimental: Dose Expansion in Mesothelioma
    Participants with MTAP-deleted mesothelioma will receive TNG462 at the identified RP2D(s)
  • Experimental: Dose Expansion in Pancreatic Ductal Adenocarcinoma
    Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG462 at the identified RP2D(s)
  • Experimental: Dose Expansion in Sarcoma
    Participants with MTAP-deleted sarcoma (soft tissue or bone) will receive TNG462 at the identified RP2D(s)
  • Experimental: Dose Expansion in Solid Tumors
    Participants with other MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s)
  • Experimental: Dose Expansion in NSCLC in Combination with Pembrolizumab
    Participants NSCLC (squamous and non squamous) MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s)

Primary Outcome Measure

Phase 1 Maximum Tolerated Dose [ Time Frame: 28 days and 21 days ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Christopher Chen (PRINCIPAL_INVESTIGATOR)
Grand Valley OncologyGrand JunctionColorado81505
Jonathan King, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer Specialists & Research InstituteLake MaryFlorida32746-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Jose Lutzky, MD (PRINCIPAL_INVESTIGATOR)
University Chicago MedicineChicagoIllinois60637
Hedy Kindler, MD (PRINCIPAL_INVESTIGATOR)
Carle Cancer CenterUrbanaIllinois61801
Tammay Sahai, MD (PRINCIPAL_INVESTIGATOR)
Midwestern Regional Medical Center, City of Hope ChicagoZionIllinois60099
Evan Pisick, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Candace Haddox, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02214
Ibiayi Dagogo-Jack, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Cancer CenterDetroitMichigan48202
Amy Weise, DO (PRINCIPAL_INVESTIGATOR)
New York University Langone HealthNew YorkNew York10016
Salman Punekar, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Tennessee OncologyNashvilleTennessee37203
David Spigel, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Jordi Rodon Ahnert, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112
Vaia Florou, MD, MS (PRINCIPAL_INVESTIGATOR)
Next Oncology VirginiaFairfaxVirginia22031
Alexander Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By research site
Stanford University· Palo Alto, CAGrand Valley Oncology· Grand Junction, COFlorida Cancer Specialists & Research Institute· Lake Mary, FLSylvester Comprehensive Cancer Center· Miami, FLUniversity Chicago Medicine· Chicago, ILCarle Cancer Center· Urbana, IL

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