Title
TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies
Phase
Phase 1Lead Sponsor
Tizona Therapeutics, IncStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Solid Tumor LymphomaIntervention/Treatment
TTX-030 Pembrolizumab Gemcitabine nab paclitaxel docetaxelStudy Participants
56This 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.
Variable dose and schedule
Dose and schedule per standard of care
Dose and schedule per standard of care
Dose and schedule per standard of care
TTX-030 plus pembrolizumab
TTX-030 plus gemcitabine plus nab-paclitaxel
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
