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A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors
Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.
Summary
This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.
Official title: A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2020-05-28
Completion Date
2026-11-30
Last Updated
2025-12-17
Healthy Volunteers
No
Interventions
TST001
TST001 is a humanized IgG1 monoclonal antibody.
Nivolumab Injection [Opdivo]
Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies
mFOLFOX6
mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.
Gemcitabine
Chemotherapy medication
Albumin-Bound Paclitaxel
Chemotherapy medication
Locations (18)
Banner MD Anderson
Gilbert, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Yale University
New Haven, Connecticut, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Kansas, School of Medicine
Kansas City, Kansas, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering
New York, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Gabrail Cancer Research
Canton, Ohio, United States
Pennsylvania Cancer Specialist Research Institute
Gettysburg, Pennsylvania, United States
Allegheny Hospital
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
NEXT Oncology
Austin, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States