Phase Ib Trial of Finotonlimab Combined with SCT200 in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

ABSTRACT 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