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

Status: Active

Description

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

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

Locations & Contacts

California

Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available
San Francisco
UCSF Medical Center-Mount Zion
Status: Approved
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Tizona Therapeutics, Inc

Trial IDs

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