Phase I/Ib dose-escalation study of avelumab in Chinese patients with advanced solid tumors
Yi-Long Wu, Ying Cheng, Huajun Chen, Haiyan Tu, Chongrui Xu, Zhen Wang, Ying Liu, Ying Xin, Haizhou Lou, Wei Wang, Kevin Chin, Dandan Li, Di Zhao, Yanfei Gao, Wenping Xu, Hongming Pan, Yi-Long Wu, Ying Cheng, Huajun Chen, Haiyan Tu, Chongrui Xu, Zhen Wang, Ying Liu, Ying Xin, Haizhou Lou, Wei Wang, Kevin Chin, Dandan Li, Di Zhao, Yanfei Gao, Wenping Xu, Hongming Pan
Abstract
Aim: Data for avelumab (anti-PD-L1 antibody) in Chinese patients are limited. Patients & methods: Phase I/Ib, open-label, dose-escalation study of Chinese patients with advanced solid tumors. Primary study objectives were to evaluate the maximum tolerated dose (MTD) and pharmacokinetics (PK) of avelumab. Results: 24 patients received avelumab 3 mg/kg every 2 weeks (Q2W; n = 3), 10 mg/kg Q2W (n = 7), 20 mg/kg Q2W (n = 6) or 10 mg/kg weekly for 12 weeks and then Q2W thereafter (n = 8). MTD was not reached. Avelumab exposure was increased in higher dose groups. Partial responses occurred in two patients (confirmed in one patient); best overall response was stable disease in nine patients. Conclusion: Data for avelumab in Chinese patients with advanced solid tumors were consistent with previous global studies.
Trial registration: ClinicalTrials.gov NCT03523390.
Keywords: China; PD-L1; advanced solid tumors; immunotherapy; phase I.
Source: PubMed