Summary

Eligibility
for people ages 18-110 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

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 Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Keywords

Solid Tumor, Adult Gastric (gastroesophageal cancer) Advanced Solid Tumor Prostate cancer Colorectal cancer Head and neck squamous cell carcinoma Renal cell carcinoma Cancer Metastatic Solid Tumor Combination Therapy CD39 Adenosine Pathway Immunotherapy Immuno-oncology PD-1 Checkpoint Inhibitor Docetaxel Budigalimab ABBV-181 TTX-030 NSCLC Non-small cell lung cancer Breast cancer Neoplasms TTX-030, budigalimab and mFOLFOX6 TTX-030, budigalimab and docetaxel TTX-030 and mFOLFOX6 TTX-030 and budigalimab Combo 1 Combo 2 Combo 3 Combo 4 Combo 5

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

  • Chao Family Comprehensive CC, UCI accepting new patients
    Orange California 92868 United States
  • University of Southern California accepting new patients
    Los Angeles California 90007 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Trishula Therapeutics, Inc.
ID
NCT04306900
Phase
Phase 1
Study Type
Interventional
Last Updated