Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
Tango Therapeutics, Inc.
Study ID
NCT06065059
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • TNG348 — DRUG
    Ubiquitin Specific Peptidase 1 (USP1) inhibitor
  • Olaparib — DRUG
    PARP inhibitor

Study Details

The goal of this interventional clinical trial is to learn about TNG348, a ubiquitin specific peptidase 1 (USP1) inhibitor, alone and in combination with olaparib in patients with BRCA 1/2 mutant or HRD+ solid tumors. The main question\[s\] it aims to answer are: * to evaluate the safety and tolerability of single agent and combination therapy * to determine the recommended dose for Phase 2 of single agent and combination therapy * to determine the pharmacokinetics of TNG348 as a single agent and in combination therapy * to evaluate the initial antineoplastic activity as a single agent and in combination therapy Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

Key Dates

Start date
Dec 8, 2023
Status verified
Aug 2024
Primary completion
May 22, 2024
Completion
May 22, 2024

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Agent Dose Escalation
    Participants with BRCA 1/2 mutant or HRD+ solid tumors will receive escalating doses of TNG348 to estimate the MTD
  • Experimental: Combination Dose Escalation
    Participants with BRCA 1/2 mutant or HRD+ solid tumors will receive escalating doses of TNG348 in combination with olaparib to estimate the MTD
  • Experimental: Single agent dose expansion in breast cancer
    Participants with BRCA 1/2 mutant breast cancer will receive TNG348 at the identified RP2D
  • Experimental: Single agent dose expansion in ovarian cancer
    Participants with BRCA 1/2 mutant ovarian cancer will receive TNG348 at the identified RP2D
  • Experimental: Combination therapy dose expansion in breast cancer
    Participants with BRCA 1/2 mutant breast cancer will receive TNG348 in combination with olaparib at the identified RP2D
  • Experimental: Combination therapy dose expansion in ovarian cancer
    Participants with BRCA 1/2 mutant ovarian cancer will receive TNG348 in combination with olaparib at the identified RP2D
  • Experimental: Combination therapy dose expansion in pancreatic or prostate cancer
    Participants with BRCA 1/2 mutant pancreatic or prostate cancer will receive TNG348 in combination with olaparib at the identified RP2D
  • Experimental: Combination therapy dose expansion in HRD+ advanced or metastatic solid tumors
    Participants with HRD+ advanced or metastatic solid tumors will receive TNG348 in combination with olaparib at the identified RP2D

Primary Outcome Measure

To determine dosing for TNG348 alone and in combination (Phase 1 only) [ Time Frame: 21 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
HealthONEDenverColorado80218-
Mid Florida Cancer CentersOrange CityFlorida32763-
Florida Cancer SpecialistsSarasotaFlorida34232-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York University Langone HealthNew YorkNew York10016-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Denver, CO

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OncologyBreast oncologyWomen's healthGynecologic oncologyProstate oncologyMen's healthUrology
By research site
HealthONE· Denver, COMid Florida Cancer Centers· Orange City, FLFlorida Cancer Specialists· Sarasota, FLDana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYNew York University Langone Health· New York, NY

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