TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
Recruiting · NCT04485013 · Interventional (participants receive a specific treatment) · Lead sponsor: Tizona Therapeutics, Inc
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
41 locations listed across 26 US states.
- Arizona Oncology Associates - Tucson, Arizona, United States
- University of Southern California - Los Angeles, California, United States
- Hoag Memorial Hospital - Newport Beach, California, United States
- Rocky Mountain Cancer Centers - Denver, Colorado, United States
- Yale Cancer Center - New Haven, Connecticut, United States
- Christiana Care Helen F. Graham Cancer Center - Newark, Delaware, United States
- John Hopkins Kimmer Cancer Center - Washington D.C., District of Columbia, United States
- Florida Cancer Specialists - Daytona Beach, Florida, United States
- Florida Cancer Specialists - Fleming Island, Florida, United States
- Ocala Oncology Center - Ocala, Florida, United States
- AdventHealth Research Institute - Orlando, Florida, United States
- Illinois Cancer Specialists - Arlington Heights, Illinois, United States
- University of Illinois - Chicago, Illinois, United States
- Indiana University - Indianapolis, Indiana, United States
- Norton Cancer Institute - Louisville, Kentucky, United States
- American Oncology Partners, P.A. - The Center for Cancer & Blood Disorders - Bethesda, Maryland, United States
- Maryland Oncology Hematology - Silver Spring, Maryland, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- START Midwest - Grand Rapids, Michigan, United States
- Regions Hospital Cancer Care Center - Saint Paul, Minnesota, United States
- Washington University in St Louis - St Louis, Missouri, United States
- Nebraska Cancer Center Oncology Hematology West P.C. - Omaha, Nebraska, United States
- Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Stony Brook University - Stony Brook, New York, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- Zangmeister Cancer Center - Columbus, Ohio, United States
- The University of Toledo - Toledo, Ohio, United States
- University of Oklahoma - Oklahoma City, Oklahoma, United States
- University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- Vanderbilt - Ingram Cancer Center - Nashville, Tennessee, United States
- Texas Oncology - Dallas - Dallas, Texas, United States
- START Dallas - Fort Worth, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Texas Oncology - Paris - Paris, Texas, United States
- NEXT Oncology - San Antonio, Texas, United States
- NEXT Oncology Virginia - Fairfax, Virginia, United States
- Northwest Medical Specialties - Tacoma, Washington, United States
- Northwest Cancer Specialists - Vancouver, Washington, United States