Actively Recruiting
A Phase 1a/1b Study of TTX-080, an HLA-G Antagonist, Alone and with Pembrolizumab, Cetuximab, or FOLFIRI Plus Cetuximab for Advanced Solid Cancers
Led by Tizona Therapeutics, Inc · Updated on 2026-02-18
240
Participants Needed
41
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and recommended Phase 2 dose of TTX-080, an HLA-G inhibitor, alone and in combination with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. This Phase 1, open-label trial includes patients with advanced refractory or resistant solid cancers, such as metastatic colorectal cancer and other types like head and neck squamous cell carcinoma, non-small cell lung cancer, triple-negative breast cancer, renal cell carcinoma, and acral melanoma. The study consists of dose escalation and dose expansion phases. Participants may receive TTX-080 as monotherapy or combined with pembrolizumab (a PD-1 inhibitor), cetuximab (an EGFR inhibitor), or FOLFIRI plus cetuximab chemotherapy regimens. Different arms focus on specific cancer types and treatment histories, including randomized arms comparing TTX-080 with FOLFIRI plus cetuximab versus FOLFIRI plus cetuximab alone for metastatic colorectal cancer patients. Participants will undergo assessments over up to 48 months, including tumor response evaluations using RECIST 1.1 criteria, pharmacokinetic and immunogenicity testing, and monitoring for adverse events and tolerability. Researchers will track various outcomes such as duration of response, progression-free survival, overall survival, and drug concentration levels to understand TTX-080's activity and safety profile.
CONDITIONS
Brief Title
TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of advanced or metastatic cancer (currently enrolling colorectal cancer only)
- Evidence of measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Willing and able to provide informed consent
You will not qualify if you...
- History of allergy or severe hypersensitivity to study treatment components or monoclonal antibodies
- Use of any investigational drug within 28 days before starting study treatment
- Receiving high-dose systemic steroids or other immunosuppressive therapies
- History of severe autoimmune disease
- Uncontrolled illness or other active cancer requiring ongoing treatment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 months
Participants receive TTX-080 alone or in combination with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab for advanced solid cancers.
Dosing every 2 to 3 weeks depending on treatment regimen
Trial Site Locations
Total: 41 locations
1
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
Completed
2
University of Southern California
Los Angeles, California, United States, 90033
Completed
3
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Completed
4
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
5
Yale Cancer Center
New Haven, Connecticut, United States, 06511
Completed
6
Christiana Care Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
Completed
7
John Hopkins Kimmer Cancer Center
Washington D.C., District of Columbia, United States, 20016
Completed
8
Florida Cancer Specialists
Daytona Beach, Florida, United States, 32117
Actively Recruiting
9
Florida Cancer Specialists
Fleming Island, Florida, United States, 32003
Completed
10
Ocala Oncology Center
Ocala, Florida, United States, 34474
Actively Recruiting
11
AdventHealth Research Institute
Orlando, Florida, United States, 32804
Completed
12
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Completed
13
University of Illinois
Chicago, Illinois, United States, 60612
Completed
14
Indiana University
Indianapolis, Indiana, United States, 46202
Completed
15
Norton Cancer Institute
Louisville, Kentucky, United States, 40241
Completed
16
American Oncology Partners, P.A. - The Center for Cancer & Blood Disorders
Bethesda, Maryland, United States, 20817
Actively Recruiting
17
Maryland Oncology Hematology
Silver Spring, Maryland, United States, 20904
Actively Recruiting
18
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Completed
19
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
20
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
21
Washington University in St Louis
St Louis, Missouri, United States, 63110
Completed
22
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska, United States, 68130
Actively Recruiting
23
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
24
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Completed
25
Stony Brook University
Stony Brook, New York, United States, 11794
Completed
26
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
27
Zangmeister Cancer Center
Columbus, Ohio, United States, 43219
Completed
28
The University of Toledo
Toledo, Ohio, United States, 43606
Completed
29
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
30
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Completed
31
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Completed
32
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
33
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Completed
34
Texas Oncology - Dallas
Dallas, Texas, United States, 75246
Actively Recruiting
35
START Dallas
Fort Worth, Texas, United States, 76104
Actively Recruiting
36
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Completed
37
Texas Oncology - Paris
Paris, Texas, United States, 75460
Actively Recruiting
38
NEXT Oncology
San Antonio, Texas, United States, 78229
Completed
39
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
40
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Completed
41
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Completed
Research Team
T
Tizona Therapeutics, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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