This study is in progress, not accepting new patients

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

a study on Solid Tumor Immunotherapy Neoplasms

Summary

Eligibility
for people ages 18-110 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Zev Wainberg

Description

Summary

This is a phase 1/1b study of TTX-030 in combination therapy, 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, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

Official Title

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Keywords

Solid Tumor, Adult, Gastric (gastroesophageal cancer), Advanced Solid Tumor, Colorectal cancer, Cancer, Metastatic Solid Tumor, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy Immuno-oncology, PD-1 Checkpoint Inhibitor, Docetaxel, Budigalimab, ABBV-181, TTX-030, Non-small cell lung cancer, Urothelial cell cancer, Pancreatic cancer, Pembrolizumab, Keytruda, Bladder cancer, Gemcitabine, Nab-paclitaxel, Neoplasms, Paclitaxel, Albumin-Bound Paclitaxel, TTX-030, budigalimab and mFOLFOX6, TTX-030, budigalimab and docetaxel, TTX-030 and mFOLFOX6, TTX-030 and budigalimab, TTX-030, budigalimab, nab-paclitaxel and gemcitabine, TTX-030 and pembrolizumab, TTX-030, nab-paclitaxel and gemcitabine, Budigalimab and mFOLFOX6

Eligibility

For people ages 18-110

Abbreviated Inclusion Criteria:

  1. Age 18 years or older, is willing and able to provide informed consent
  2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
  3. Life expectancy > 12 weeks
  4. 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

  • UCLA Hematology/Oncology
    Los Angeles California 90404 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States
  • University of Southern California
    Los Angeles California 90007 United States
  • City of Hope Medical Center Clinical Trials Office
    Duarte California 91010 United States

Lead Scientist at UCLA

  • Zev Wainberg
    HS Clinical Professor, Medicine. Authored (or co-authored) 138 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Trishula Therapeutics, Inc.
ID
NCT04306900
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 185 study participants
Last Updated