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Title: A phase 1a/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors.
Austin Authors: Frentzas, Sophia;Gan, Hui K ;Cosman, Rasha;Coward, Jermaine;Tran, Ben;Millward, Michael;Zhou, Yiting;Wang, Wenjing;Xia, Dennis;Wang, Zhongmin Maxwell;Li, Baiyong;Xia, Michelle;Desai, Jayesh
Affiliation: Department of Medical Oncology, Monash Health, Melbourne, Australia; Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.
Medical Oncology
The Kinghorn Cancer Centre, St Vincent's Hospital, Sydney, Australia; St. Vincent's Clinical School, University of New South Wales, Sydney, Australia.
ICON Cancer Centre, Brisbane, Australia; University of Queensland, Faculty of Medicine, Brisbane, Australia.
Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Linear Clinical Research, Nedland, Perth, Australia; School of Medicine, University of Western Australia, Perth, Australia.
Akeso Biopharma, Inc., Zhongshan, China.
Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Australia.
Issue Date: 21-Nov-2023
Date: 2023
Publication information: Cell Reports. Medicine 2023; 4(11)
Abstract: Simultaneous inhibition of programmed cell death protein-1 (PD-1) and cytotoxic T lymphocyte-associated protein-4 (CTLA-4) with bispecific antibodies may improve efficacy over single-agent treatment while limiting toxicity. Cadonilimab is a humanized, bispecific antibody targeting PD-1 and CTLA-4. This is a phase 1 study of cadonilimab including dose escalation (n = 39) and dose expansion (n = 80). One dose-limiting toxicity event is observed, with the maximum tolerated dose not reached. 6 mg/kg cadonilimab once every 2 weeks is established as the recommended dose for future studies. The most common treatment-related adverse event is infusion-related reaction (18.5%), mostly grade 1/2 in severity. The incidences of any grade and grade ≥3 immune-related adverse events are 44.5% and 6.7%, respectively. The confirmed overall response rate is 13.4%, and the median duration of response is 12.9 months. Cadonilimab is well tolerated and showed promising efficacy in patients with advanced solid tumors. This study is registered with NCT03261011.
DOI: 10.1016/j.xcrm.2023.101242
Journal: Cell Reports. Medicine
Start page: 101242
PubMed URL: 37852261
ISSN: 2666-3791
Type: Journal Article
Subjects: CTLA-4
advanced solid tumors
bispecific antibody
immune checkpoint inhibitor
Appears in Collections:Journal articles

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