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
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Frankos, Marie; Grofsik, Kiera; Britton, David
Trial Phone: 321.841.9821 ; 321.841.7303 ; 321.841.6626 ; 321.841.2684
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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
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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.
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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
