This study is in progress, not accepting new patients

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

a study on Solid Tumor Lymphoma Immunotherapy

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
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, 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
    • 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.
  2. Age 18 years or older, is willing and able to provide informed consent
  3. Evidence of measurable disease
  4. 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

  • UCSF
    San Francisco California 94143 United States
  • UC Davis Comprehensive Cancer Center
    Sacramento California 95817 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Trishula Therapeutics, Inc.
ID
NCT03884556
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 56 people participating
Last Updated