TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers

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.

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

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

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Tizona Therapeutics, Inc

• Primary ID TTX-030-001
• Secondary IDs NCI-2019-05303
• Clinicaltrials.gov ID NCT03884556