@article{fef291ec37b044ed95a790b0a6381a89,
title = "A phase 1a/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors",
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 ClinicalTrials.gov: NCT03261011.",
keywords = "advanced solid tumors, bispecific antibody, cadonilimab, CTLA-4, immune checkpoint inhibitor, PD-1",
author = "Sophia Frentzas and Gan, {Hui K.} and Rasha Cosman and Jermaine Coward and Ben Tran and Michael Millward and Yiting Zhou and Wenjing Wang and Dennis Xia and Wang, {Zhongmin Maxwell} and Baiyong Li and Michelle Xia and Jayesh Desai",
note = "Funding Information: This study was supported by Akeso Biopharma, Inc. , Zhongshan, China. The authors thank all the patients who participated in this study and the investigators and research staff at all study sites. Benchao Chen, Jiawen Tang, and Min Zhang from Akeso Biopharma contributed to PK and PD data analysis, and Yumei Shi and Cunnan Dong from Akeso Biopharma provided professional assistance for the medical review and manuscript preparation. Editorial assistance was provided by Joyce Lee, PhD, CMPP of Nucleus Global Asia Pacific, funded by Akeso Biopharma in accordance with Good Publication Practice (GPP3) guidelines. Publisher Copyright: {\textcopyright} 2023",
year = "2023",
month = nov,
day = "21",
doi = "10.1016/j.xcrm.2023.101242",
language = "English",
volume = "4",
journal = "Cell Reports Medicine",
issn = "2666-3791",
publisher = "Cell Press",
number = "11",
}