Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

February 21, 2018

Primary Completion Date

June 7, 2022

Study Completion Date

July 7, 2022

Conditions
Advanced Malignancies
Interventions
BIOLOGICAL

Part A

Part A: 80, 240, and 480 mg IV every 14 days.

BIOLOGICAL

Part B

Part B: 240 mg IV every 3 weeks

Trial Locations (14)

21201

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore

21231

Sidney Kimmel Comprehensive Cancer Center, Baltimore

28078

Carolina BioOncology Institute, Huntersville

33136

University of Miami Hospital Sylvester Comprehensive Cancer Center, Miami

34238

Florida Cancer Specialists, Sarasota

37203

Sarah Cannon Research Institute, Nashville

37232

Vanderbilt University Medical Center, Nashville

44101

University Hospitals Seidman Cancer Center, Cleveland

48201

Karmanos Cancer Institute, Detroit

55901

Mayo Clinic-Rochester, Rochester

77030

MD Anderson Cancer Center, Houston

80045

University of Colorado Denver, Aurora

90404

Sarcoma Oncology Research Center, Santa Monica

02906

Rhode Island Hospital, Providence

Sponsors
All Listed Sponsors
collaborator

Shanghai Junshi Bioscience Co., Ltd.

OTHER

lead

TopAlliance Biosciences

INDUSTRY

NCT03474640 - Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies | Biotech Hunter | Biotech Hunter