A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC

Summary

This study is conducted in patients with Locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. This study includes three arms: A, B1, and B2. Arm A will receive HLX07 combination therapy with HLX10 and Chemotherapy (Cisplatin+5-FU) as first line treatment. Arm B (Patients with EGFR expression H score ≥ 200) and Arm C (Patients with EGFR expression H score \< 200) will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Timeline

Start

2022-08-25

Primary completion

2024-06-30

Completion

2025-08-30

Publications

• Liu Y, Wang Y, Zhu Y, Wu T, Liu Z, Zhou J, Yuan Y, Yang M, Liu B, Tan Z, Zhuang W, Chen J, Li N, Wang Y, Hu X, Wang L, Yu H, Wang Q, Zhu J, Huang J. HLX07 alone or combined with serplulimab, cisplatin and 5-fluorouracil for advanced esophageal squamous cell carcinoma: A phase 2 study. Cancer Commun (Lond). 2024 Dec;44(12):1431-1443. doi: 10.1002/cac2.12621. Epub 2024 Oct 24.

Drugs

Indications