Breast Cancer Clinical Trial

TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers

Summary

TTX-080-01 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) or cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies.

The study is enrolling in the dose expansion cohorts.

View Full Description

Full Description

TTX-080 is a fully human mAb designed to block the interaction of HLA-G with its known ligands, ILT2 and ILT4 molecules. The Phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD or OBD and the RP2D of TTX-080 when administered as a single agent. The Phase 1b is a dose expansion of TTX-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory/resistant solid malignancies, including Head and Neck squamous cell carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Colorectal cancer (CRC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), and acral melanoma. Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of TTX-080, and preliminary efficacy of TTX-080 as a monotherapy and in combination with pembrolizumab or cetuximab.

The study is enrolling in the dose expansion cohorts.

View Eligibility Criteria

Eligibility Criteria

Abbreviated Inclusion Criteria:

Subject with histological diagnosis of advanced/metastatic cancer
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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

240

Study ID:

NCT04485013

Recruitment Status:

Recruiting

Sponsor:

Tizona Therapeutics, Inc

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There are 39 Locations for this study

See Locations Near You

Arizona Oncology Associates
Tucson Arizona, 85711, United States More Info
Contact
520-886-0206
University of Southern California
Los Angeles California, 90033, United States
University of California, Los Angeles
Los Angeles California, 90095, United States More Info
Contact
310-633-8400
Hoag Memorial Hospital
Newport Beach California, 92663, United States More Info
Contact
949-764-5914
Yale Cancer Center
New Haven Connecticut, 06511, United States More Info
Contact
203-737-5342
Christiana Care Helen F. Graham Cancer Center
Newark Delaware, 19713, United States More Info
Contact
302-623-4639
John Hopkins Kimmer Cancer Center
Washington District of Columbia, 20016, United States More Info
Contact
202-660-6500
Florida Cancer Specialists
Daytona Beach Florida, 32117, United States More Info
Contact
386-231-4060
Florida Cancer Specialists
Fleming Island Florida, 32003, United States More Info
904-269-6526
Contact
Ocala Oncology Center
Ocala Florida, 34474, United States More Info
Contact
352-547-1958
AdventHealth Research Institute
Orlando Florida, 32804, United States More Info
Contact
407-200-2901
Illinois Cancer Specialists
Arlington Heights Illinois, 60005, United States More Info
Contact
847-259-4482
University of Illinois
Chicago Illinois, 60612, United States More Info
Contact
312-413-2655
Indiana University
Indianapolis Indiana, 46202, United States More Info
Contact
317-274-3502
Norton Cancer Institute
Louisville Kentucky, 40241, United States
Maryland Oncology Hematology
Silver Spring Maryland, 20904, United States More Info
Contact
301-933-3216
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Contact
617-582-8705
START Midwest
Grand Rapids Michigan, 49546, United States More Info
Contact
616-954-5559
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States More Info
Contact
651-254-3602
Washington University in St Louis
Saint Louis Missouri, 63110, United States More Info
Contact
314-362-9427
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha Nebraska, 68130, United States More Info
Contact
402-691-6971
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
Contact
732-235-3253
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Contact
212-241-7840
Stony Brook University
Stony Brook New York, 11794, United States More Info
Contact
631-722-2623
University of Cincinnati
Cincinnati Ohio, 45267, United States More Info
Contact
513-584-5680
Zangmeister Cancer Center
Columbus Ohio, 43219, United States More Info
Contact
614-383-6000
The University of Toledo
Toledo Ohio, 43606, United States More Info
Contact
419-383-6925
University of Oklahoma
Oklahoma City Oklahoma, 73104, United States More Info
Contact
405-271-8001
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States More Info
Contact
412-647-8587
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Contact
615-524-4203
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Contact
615-936-6788
Texas Oncology - Dallas
Dallas Texas, 75246, United States More Info
Contact
214-370-1000
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Oncology - Paris
Paris Texas, 75460, United States More Info
Contact
903-785-0031
NEXT Oncology
San Antonio Texas, 78229, United States
NEXT Oncology Virginia
Fairfax Virginia, 22031, United States More Info
Contact
703-280-5290
Northwest Medical Specialties
Tacoma Washington, 98405, United States More Info
Contact
253-428-8738
Northwest Cancer Specialists
Vancouver Washington, 98684, United States More Info
Contact
360-944-9889

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

240

Study ID:

NCT04485013

Recruitment Status:

Recruiting

Sponsor:


Tizona Therapeutics, Inc

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