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Phase I

A First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors

  • Study HIC#:2000029131
  • Last Updated:02/05/2023

This is a Phase 1, multicenter, open-label, multiple-dose, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, and pharmacodynamics of TTX-080 monotherapy in subjects with advanced or metastatic solid tumors known to express HLA-G.

This first-in-human (FIH) study has been designed to evaluate the safety, tolerability, and preliminary antitumor activity of TTX-080 as monotherapy in adults with unresectable or metastatic solid tumors known to express HLA-G.

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    Trial Purpose and Description

    Primary Outcome Measures  :

    1. Recommended Phase 2 Dose (RP2D) [ Time Frame: 1 cycle (each cycle is 21 days) ]To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule

    Eligibility Criteria

    Abbreviated Inclusion Criteria:

    1. Subject with histological or cytological diagnosis of advanced/metastatic cancer
    2. Age 18 years or older, is willing and able to provide informed consent
    3. Evidence of measurable disease
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

    Abbreviated Exclusion Criteria:

    1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
    2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
    3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
    4. History of severe autoimmune disease
    5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment


    For more information about this study, including how to volunteer, contact: