NCT04485013Active, not recruitingPhase 1
TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 15 Jul 2020
- Start date
- 14 Jul 2020
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Tizona Therapeutics, Inc
- Diseases
- Prostate cancer, Triple-negative breast cancer, Head and neck cancer, Kidney cancer, Bladder cancer, Melanoma, Endometrial cancer, Cervical cancer, Lung cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT04485013
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 240
- From 14 Jul 2020 to the primary completion date, 1 Jun 2027
- 41 sites in 1 country
- 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:
- Subject with histological diagnosis of advanced/metastatic cancer \[currently enrolling in CRC only\]
- Age 18 years or older, is willing and able to provide informed consent
- Evidence of measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks
- Abbreviated Exclusion Criteria:
- History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
- Use of an 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 - · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Arlington Heights | United States | Unknown status |
| American Oncology Partners, P.A. - The Center for Cancer & Blood Disorders Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Zangmeister Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Texas Oncology - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| Rocky Mountain Cancer Centers Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| NEXT Oncology- Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Fleming Island | United States | Unknown status |
| START Dallas Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | 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 |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Christiana Care Helen F. Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Hoag Memorial Hospital Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Ocala Oncology Center Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Nebraska Cancer Center Oncology Hematology West P.C. Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| AdventHealth Research Institute Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Texas Oncology - Paris Coordinator of this site? Confirm its status | Paris | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Regions Hospital Cancer Care Center Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Maryland Oncology Hematology Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Stony Brook University Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Northwest Medical Specialties Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| The University of Toledo Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Arizona Oncology Associates Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Northwest Cancer Specialists Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
| John Hopkins Kimmer Cancer Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.