Spots Global Cancer Trial Database for TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
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Trial Identification
Brief Title: TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
Official Title: A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab or Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies
Study ID: NCT04485013
Conditions
Study Description
Brief Summary: 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) or cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, Tucson, Arizona, United States
University of Southern California, Los Angeles, California, United States
University of California, Los Angeles, 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, 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
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, Saint 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
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
Contact Details
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