NCT04306900CompletedPhase 1
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
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
Source: ClinicalTrials.gov · Last updated 29 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 185 (actual)
- First submitted
- 4 Mar 2020
- Start date
- 30 Mar 2020
- Primary completion date
- 30 Nov 2022
- Lead sponsor
- Trishula Therapeutics, Inc.
- NCT number
- NCT04306900
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 185
- From 30 Mar 2020 to the primary completion date, 30 Nov 2022
- 32 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Abbreviated Inclusion Criteria:
- Age 18 years or older, is willing and able to provide informed consent
- Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
- Life expectancy \> 12 weeks
- ECOG performance status of 0-1
- Abbreviated 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
Age in the registry: 18 years to 110 years · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Gangnam-Gu | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Ilsandong-gu | South Korea | Unknown status |
| Severance Hospital Yonsei University Coordinator of this site? Confirm its status | Seodaemun-gu | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Seogu | South Korea | Unknown status |
| Seoul National University Coordinator of this site? Confirm its status | Seongnam-si Bundan-gu | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Songpa-gu | South Korea | Unknown status |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| IACT Health - John B. Amos Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| City of Hope Medical Center Clinical Trials Office Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| West Cancer Center and Research Institute Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Prisma Health Cancer Institute Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UCLA Hematology-Oncology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Froedtert Hospital/Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Ochsner Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Ocala Oncology Center PL Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Nebraska Cancer Center Oncology Hematology West P.C. Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Chao Family Comprehensive CC, UCI Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Orlando Health UF Health Cancer Center Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| UC Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Hunstman Cancer Intitute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| HonorHealth Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| University of Toledo Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.