1. Phase Ib study of SCT200 combined with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma following platinum-based chemotherapy and PD-1 antibody.
- Author
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Lin J, Qu S, Yang K, Zhang T, Bai Y, Wu J, Huang Y, Fang M, Liu X, Huang X, Chen N, Li Z, Li W, Zhang S, Zhang S, Hu G, Sun Y, Chen X, Liu Y, Jing S, Shen L, Chang Z, Xie L, Gai W, Zhou Q, Chen X, Yi J, and Guo Y
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Adult, Immune Checkpoint Inhibitors administration & dosage, Immune Checkpoint Inhibitors adverse effects, Immune Checkpoint Inhibitors therapeutic use, Programmed Cell Death 1 Receptor antagonists & inhibitors, Programmed Cell Death 1 Receptor immunology, ErbB Receptors antagonists & inhibitors, Progression-Free Survival, Paclitaxel administration & dosage, Paclitaxel adverse effects, Paclitaxel therapeutic use, Docetaxel administration & dosage, Docetaxel therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Squamous Cell Carcinoma of Head and Neck drug therapy, Squamous Cell Carcinoma of Head and Neck pathology, Squamous Cell Carcinoma of Head and Neck mortality, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local pathology, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized therapeutic use, Head and Neck Neoplasms drug therapy, Head and Neck Neoplasms pathology
- Abstract
Treatment options for recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) are limited, especially for patients who progress after immune checkpoint inhibitor (ICI) therapy. This phase Ib study investigates the efficacy and safety of SCT200, an epidermal growth factor receptor (EGFR) antibody, combined with paclitaxel or docetaxel in R/M HNSCC patients who have failed both platinum-based chemotherapy and programmed cell death protein 1 (PD-1) inhibitors. This was a multicenter, open-label study enrolling patients with resistance or intolerance to platinum-based chemotherapy and PD-1 inhibitors. Patients received intravenous SCT200 (6 mg/kg weekly for 12 weeks, followed by 8 mg/kg every two weeks). Paclitaxel (80 mg/m
2 weekly) or docetaxel (75 mg/m2 every three weeks) was administered according to the patient's prior paclitaxel treatment history. The primary endpoint was objective response rate (ORR). Thirty patients were included in the efficacy and safety analyses. The ORR was 26.7 % (95 % confidence interval [CI]: 12.3-45.9). The median progression-free survival (PFS) was 4.1 months (95 % CI: 2.7-5.7), and the median overall survival (OS) was 8.7 months (95 % CI: 5.0-11.9). For patients receiving SCT200 with docetaxel, median PFS was 5.7 months, and OS was 9.5 months. Common adverse events (AEs) included hypomagnesemia, acneiform dermatitis, and rash. No unexpected safety signals were observed. SCT200 in combination with paclitaxel or docetaxel shows promising efficacy in patients with R/M HNSCC following platinum-based chemotherapy and PD-1 inhibitors, warranting further investigation. ClinicalTrials.gov identifier: NCT05552807., Competing Interests: Declaration of competing interest L.X., W.G., Q.Z. Xinyue Chen and J.Y. are employees of Sinocelltech Ltd., Beijing, China. The other authors, who are investigators involved in this study, declare no competing interests., (Copyright © 2025 Elsevier B.V. All rights reserved.)- Published
- 2025
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