Authors
Yuankai Shi, Qingyuan Zhang, Wei Wang, Jianhua Shi, Xiaodong Zhu, Kunyu Yang, Lin Wang, Guoqing Li, Peiguo Wang, Lin Gui
Published in
Cancer pathogenesis and therapy. Volume 4. Issue 5. Pages 402-411. Epub Jan 10, 2026.
Abstract
There are limited treatment options for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) progressing after platinum-based therapy. Epidermal growth factor receptor (EGFR)-targeting monoclonal antibodies (mAbs) have demonstrated efficacy in R/M HNSCC. This phase 2 study evaluated the efficacy and safety of SCT200, a novel fully humanized EGFR mAb, in Chinese patients with R/M HNSCC progressing after platinum-based therapy.
This was a single-arm, multi-center phase 2 study, which enrolled patients with R/M HNSCC who had progressed after ≥2 cycles of platinum-based therapy. All patients received SCT200 at 6.0 mg/kg weekly for the first 6 weeks, followed by 8.0 mg/kg every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR).
Between November 14, 2018, and April 2, 2020, 36 patients were enrolled. The ORR was 13.9% (5/36, 95% confidence interval [CI]: 4.7-29.5), the complete response rate was 2.8% (1/36), while the partial response rate was 11.1% (4/36). The disease control rate was 69.4% (25/36, 95% CI: 51.9-83.7). The median time to response was 1.38 months (95% CI: 0.99-2.60). The median duration of response was 5.95 months (95% CI: 2.60-not reached [NR]). The median progression-free survival and overall survival were 3.98 months (95% CI: 2.76-5.32) and 8.77 months (95% CI: 6.64-NR), respectively. Grade ≥3 treatment-related adverse events occurred in 44.4% (16/36) of patients, with the most common being hypomagnesemia (7/36, 19.4%, 95% CI: 8.2-36.0), hypokalemia (3/36, 8.3%, 95% CI: 1.8-22.5), rash (2/36, 5.6%, 95% CI: 0.7-18.7), and anemia (2/36, 5.6%, 95% CI: 0.7-18.7).
This study demonstrated promising efficacy and a manageable safety profile of SCT200 in patients with R/M HNSCC progressing after platinum-based chemotherapy.
Clinical Trials.gov, NCT03713372; https://www.clinicaltrials.gov.
PMID:
42668534
Bibliographic data and abstract were imported from PubMed on 30 Aug 2026.
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