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.
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.
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
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There are 40 Locations for this study
Tucson Arizona, 85711, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Newport Beach California, 92663, United States
Denver Colorado, 80218, United States
New Haven Connecticut, 06511, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20016, United States
Daytona Beach Florida, 32117, United States
Fleming Island Florida, 32003, United States
Ocala Florida, 34474, United States
Orlando Florida, 32804, United States
Arlington Heights Illinois, 60005, United States
Chicago Illinois, 60612, United States
Indianapolis Indiana, 46202, United States
Louisville Kentucky, 40241, United States
Silver Spring Maryland, 20904, United States
Boston Massachusetts, 02215, United States
Grand Rapids Michigan, 49546, United States
Saint Paul Minnesota, 55101, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68130, United States
New Brunswick New Jersey, 08903, United States
New York New York, 10029, United States
Stony Brook New York, 11794, United States
Cincinnati Ohio, 45267, United States
Columbus Ohio, 43219, United States
Toledo Ohio, 43606, United States
Oklahoma City Oklahoma, 73104, United States
Pittsburgh Pennsylvania, 15232, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Paris Texas, 75460, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
Tacoma Washington, 98405, United States
Vancouver Washington, 98684, United States
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