A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects with Advanced Malignancies
Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Enrolling: Male and Female Patients
IRB Number: AAAS3710
U.S. Govt. ID: NCT03474640
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to determine if the study drug toripalimab is safe, to determine future doses to give to patients with cancer, and to measure the amount of toripalimab in the blood. Up to approximately 240 subjects will be enrolled in Part B. The dose given in Part B will be 240 mg. The dose was chosen based upon safety data obtained from subjects participating in clinical trials with toripalimab in China and from subjects participating in Part A of this study in the United States. The first 20 subjects enrolled in Part B will have more frequent blood draws in Cycles 1 through 6 to evaluate the level of toripalimab in the blood.
This study is closed
Investigator
Gary Schwartz, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Have you been diagnosed with soft tissue sarcoma? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162