Bladder Cancer Clinical Trial
TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Summary
This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.
This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
Eligibility Criteria
Abreviated Inclusion Criteria
Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
eligible to receive single-agent pembrolizumab as standard of care, or
eligible to receive single-agent docetaxel as standard of care, or
advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care.
Age 18 years or older, is willing and able to provide informed consent
Evidence of measurable disease
Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Abbreviated Exclusion Criteria
History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
History of severe autoimmune disease
Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
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There are 16 Locations for this study
Orange California, 92868, United States
Sacramento California, 95817, United States
San Francisco California, 94143, United States
Miami Florida, 33136, United States
Louisville Kentucky, 40202, United States
Omaha Nebraska, 68130, United States
New Brunswick New Jersey, 08903, United States
Bronx New York, 10461, United States
New York New York, 10032, United States
New York New York, 10065, United States
Cleveland Ohio, 44122, United States
Pittsburgh Pennsylvania, 15232, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States
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