Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion

Description

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.

Official Title

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

Keywords

Solid Tumor Lymphoma Cancer Metastatic Solid Tumors Advanced Solid Tumors Relapsed/Refractory Lymphoma Prostrate Cancer Pancreatic Cancer Monotherapy Combination Therapy CD39 Adenosine Pathway Immunotherapy Immuno-oncology PD-1 Checkpoint Inhibitor Nab-paclitaxel Gemcitabine Pembrolizumab Docetaxel Bladder Cancer Lung Cancer Paclitaxel Albumin-Bound Paclitaxel TTX-030 nab paclitaxel

Eligibility

For people ages 18 years and up

Abreviated Inclusion Criteria

  1. Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
  2. eligible to receive single-agent pembrolizumab as standard of care, or
  3. eligible to receive single-agent docetaxel as standard of care, or
  4. advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care.
  5. Age 18 years or older, is willing and able to provide informed consent
  6. Evidence of measurable disease
  7. Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (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

Locations

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Hunstman Cancer Intitute accepting new patients
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tizona Therapeutics, Inc
ID
NCT03884556
Phase
Phase 1
Study Type
Interventional
Last Updated