Cancer medicine · 2026
Phase Ib Trial of Finotonlimab Combined With SCT200 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
СтатьяКлиническое исследование I фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Lin Jinguan, Qu Song, Yang Kunyu, Zhang Tao, Bai Yuansong, Wu Jian, Huang Yanjing, Fang Meiyu, Liu Xianling, Huang Xiaoming, Chen Nianyong, Li Zhendong, Li Weidong, Zhang Songnan, Zhang Shurong, Hu Guangyuan, Sun Yan, Chen Xiaohong, Liu Yanyan, Jing Shanghua, Shen Liangfang, Chang Zhiwei, Xie Liangzhi, Gai Wenlin, Wang Yan, Chen Xinyue, Liu Dongfang, Guo Ye
Аннотация
BACKGROUND: Effective treatment options remain limited for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), including patients who have progressed after platinum-based chemotherapy and systemic-therapy-naïve patients. This Phase Ib trial evaluates the efficacy and safety of finotonlimab, a PD-1 antibody, combined with SCT200, an EGFR antibody.
METHODS: This prospective, multicenter, open-label study enrolled patients into two cohorts: Cohort A (previously treated with platinum-based chemotherapy and immune checkpoint inhibitors) and Cohort B (systemic therapy-naïve). Patients received finotonlimab (200 mg every 3 weeks) and SCT200 (6 mg/kg weekly for 12 weeks, then 8 mg/kg every 2 weeks). The primary endpoint was objective response rate (ORR).
RESULTS: Among 41 patients, Cohort A (n = 11) showed an ORR of 27.3%, median progression-free survival (PFS) of 5.8 months, and median overall survival (OS) of 10.6 months. Cohort B (n = 30) had an ORR of 56.7%, median PFS of 9.6 months, and an estimated median OS of 13.6 months. Common treatment-related adverse events included hypomagnesemia (63.4%), rash (41.5%), and acneiform dermatitis (36.6%), which were manageable.
CONCLUSIONS: The combination of finotonlimab and SCT200 demonstrates promising efficacy, particularly in systemic therapy-naïve patients, warranting further investigation.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05552807; Chinadrugtrials.org.cn identifier: CTR20220917.
METHODS: This prospective, multicenter, open-label study enrolled patients into two cohorts: Cohort A (previously treated with platinum-based chemotherapy and immune checkpoint inhibitors) and Cohort B (systemic therapy-naïve). Patients received finotonlimab (200 mg every 3 weeks) and SCT200 (6 mg/kg weekly for 12 weeks, then 8 mg/kg every 2 weeks). The primary endpoint was objective response rate (ORR).
RESULTS: Among 41 patients, Cohort A (n = 11) showed an ORR of 27.3%, median progression-free survival (PFS) of 5.8 months, and median overall survival (OS) of 10.6 months. Cohort B (n = 30) had an ORR of 56.7%, median PFS of 9.6 months, and an estimated median OS of 13.6 months. Common treatment-related adverse events included hypomagnesemia (63.4%), rash (41.5%), and acneiform dermatitis (36.6%), which were manageable.
CONCLUSIONS: The combination of finotonlimab and SCT200 demonstrates promising efficacy, particularly in systemic therapy-naïve patients, warranting further investigation.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05552807; Chinadrugtrials.org.cn identifier: CTR20220917.