TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Trial Status: Active
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.
- 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
- 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
University of California Davis Comprehensive Cancer Center
UCSF Medical Center-Mount Zion
Contact: Helen Diller Family Comprehensive Cancer Center
University of Miami Miller School of Medicine-Sylvester Cancer Center
Rutgers Cancer Institute of New Jersey
Memorial Sloan Kettering Cancer Center
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Case Comprehensive Cancer Center
University of Pittsburgh Cancer Institute (UPCI)
Salt Lake City
Huntsman Cancer Institute / University of Utah
Trial Phase Phase I
Trial Type Treatment
Trishula Therapeutics, Inc.
- Primary ID TTX-030-001
- Secondary IDs NCI-2019-05303
- Clinicaltrials.gov ID NCT03884556