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Jason D Lickliter, 1 Hui K Gan, 2–4 Mark Voskoboynik, 1, 5, 6 Surein Arulananda, 2–4 Bo Gao, 7 Adnan Nagrial, 7 Peter Grimison, 8 Michelle Harrison, 8 Jianjun Zou, 9 Lianshan Zhang, 9 Stacey Luo, 9 Michael Lahn, 10 Howard Kallender, 11 Andrea Mannucci, 10 Catello Somma, 10 Katherine Woods, 3 Andreas Behren, 3, 4 Pablo Fernandez-Penas, 12 Michael Millward, 13 Tarek Meniawy 13 1Nucleus Network, Melbourne, Victoria, Australia; 2Department of Medicine, University of Melbourne, Heidelberg, Victoria, Australia; 3Olivia Newton-John Cancer Wellness and Research Centre, Austin Hospital, Melbourne, Victoria, Australia; 4Department of Medical Oncology, La Trobe University School of Cancer Medicine, Bundoora, Victoria, Australia; 5Department of Medical Oncology, Alfred Hospital, Melbourne, Victoria, Australia; 6Department of Medical Oncology, Monash University, Central Clinical School, Alfred Campus, Melbourne, Victoria, Australia; 7Blacktown Cancer and Haematology Centre, Blacktown Hospital, University of Sydney, Sydney, New South Wales, Australia; 8Department of Medical Oncology, Chris O’Brien Life House, Camperdown, New South Wales, Australia; 9Jiangsu Hengrui Medicine Co. Ltd, Shanghai, People’s Republic of China; 10Incyte Biosciences International Sarl, Geneva, Switzerland; 11Incyte Corporation, Wilmington, Delaware, USA; 12Department of Dermatology, The University of Sydney, Westmead Hospital, Westmead, New South Wales, Australia; 13Linear Clinical Research, Nedlands, Western Australia, AustraliaCorrespondence: Jason D LickliterNucleus Network, Level 5, Burnet Tower, 89 Commercial Road, Melbourne, Victoria, AustraliaTel +61 3 9076 8900Fax +61 3 9076 8911Email j.lickliter@nucleusnetwork.com.auPurpose: 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.Methods: 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.Results: 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).Conclusion: Camrelizumab has manageable toxicity and encouraging preliminary antitumor activity in advanced solid tumors in Australia.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02492789.Keywords: PD-1, monoclonal antibody, first-in-human dose study, cancer, reactive cutaneous capillary endothelial proliferation