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Title: A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia.
Austin Authors: Lickliter, Jason D;Gan, Hui K ;Voskoboynik, Mark;Arulananda, Surein;Gao, Bo;Nagrial, Adnan;Grimison, Peter;Harrison, Michelle;Zou, Jianjun;Zhang, Lianshan;Luo, Stacey;Lahn, Michael;Kallender, Howard;Mannucci, Andrea;Somma, Catello;Woods, Katherine;Behren, Andreas;Fernandez-Penas, Pablo;Millward, Michael;Meniawy, Tarek
Affiliation: Blacktown Cancer and Haematology Centre, Blacktown Hospital, University of Sydney, Sydney, New South Wales, Australia
Department of Medicine, University of Melbourne, Heidelberg, Victoria, Australia
Olivia Newton-John Cancer Wellness and Research Centre, Austin Health, Heidelberg, Victoria, Australia
Department of Medical Oncology, La Trobe University School of Cancer Medicine, Bundoora, Victoria, Australia
Nucleus Network, Melbourne, Victoria, Australia
Department of Medical Oncology, Alfred Hospital, Melbourne, Victoria, Australia
Department of Medical Oncology, Monash University, Central Clinical School, Alfred Campus, Melbourne, Victoria, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
Department of Dermatology, The University of Sydney, Westmead Hospital, Westmead, New South Wales, Australia
Department of Medical Oncology, Chris O'Brien Life House, Camperdown, New South Wales, Australia
Jiangsu Hengrui Medicine Co. Ltd, Shanghai, People's Republic of China
Incyte Biosciences International Sarl, Geneva, Switzerland
Incyte Corporation, Wilmington, Delaware, USA
Issue Date: 18-Mar-2020
Date: 2020-03-18
Publication information: Drug design, development and therapy 2020; 14: 1177-1189
Abstract: Camrelizumab inhibits PD-1 in non-clinical models and showed typical non-clinical pharmacokinetic (PK) and safety profiles for an IgG4 monoclonal antibody. We report results from the First-in-Human Phase 1 trial of camrelizumab in Australian population. Camrelizumab was administered to patients with advanced solid tumors who had failed standard therapies. In the dose-escalation phase (n=23), camrelizumab was administered intravenously at 1 mg/kg, 3 mg/kg, 6 mg/kg, and 10 mg/kg every 2 weeks. In dose expansion (n=26), camrelizumab was given at 200 mg or 600 mg every 4 weeks. Two dose-limiting toxicities were observed during dose escalation: transaminase elevation and diarrhea (both grade 3). Overall, treatment-related adverse events were consistent with the expected toxicity profile of immune checkpoint inhibition, with the striking exception of the dose-related development of angiomatous skin lesions characterized as reactive cutaneous capillary endothelial proliferation. The PK profile showed a dose-progressive increase in half-life from 3 days at 1 mg/kg to 7 days at 10 mg/kg. Moreover, receptor occupancy assays showed a PD-1 occupancy of >50% in most patients out to 28 days post-dose. The objective response rate was 15.2% (95% CI 6.3-28.9). Camrelizumab has manageable toxicity and encouraging preliminary antitumor activity in advanced solid tumors in Australia. Identifier: NCT02492789.
DOI: 10.2147/DDDT.S243787
ORCID: 0000-0002-4242-1300
Journal: Drug design, development and therapy
PubMed URL: 32256049
Type: Journal Article
Subjects: PD-1
first-in-human dose study
monoclonal antibody
reactive cutaneous capillary endothelial proliferation
Appears in Collections:Journal articles

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