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Phase 1 study to Evaluate the Safety and Activity of TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Solid Tumors

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

  • Clinical Trial Information

    Trial Contact: Donaldson, Karin M; Frankos, Marie

    Trial Phone: 321.841.9821 ; 321.841.7303

  • IRB No: 20.067.05

    Protocol Abbrev: TTX-030-002

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase I

    Age Group: Adult

    Secondary Protocol No: TTX-030-002

    Treatment: Experimental: Combo 1 TTX-030 plus budigalimab plus mFOLFOX6 Treatment: Combination Product: TTX-030, budigalimab and mFOLFOX6 Dose and schedule per protocol Experimental: Combo 2 TTX-030 plus budigalimab plus docetaxel Treatment: Combination Product: TTX-030, budigalimab and docetaxel Dose and schedule per protocol Experimental: Combo 3 TTX-030 plus mFOLFOX6 Treatment: Combination Product: TTX-030 and mFOLFOX6 Dose and schedule per protocol Experimental: Combo 4 TTX-030 plus budigalimab Treatment: Combination Product: TTX-030 and budigalimab Dose and schedule per protocol Experimental: Combo 5 TTX-030 plus budigalimab (selected tumors evaluated in expansion) Treatment: Combination Product: TTX-030 and budigalimab Dose and schedule per protocol

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT04306900

  • Objective

    This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

  • Key Eligibility

    Abbreviated Inclusion Criteria:
    1.Age 18 years or older, is willing and able to provide informed consent
    2.Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
    3.Life expectancy > 12 weeks
    4.ECOG performance status of 0-1

    Abbreviated Exclusion Criteria:
    1.History of allergy or hypersensitivity to study treatment components. Patients 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