BC001 (cetuximab biosimilar)

The trial comprised two parts: a 3 + 3 dose-escalation CDP1 monotherapy study to determine the dose for the combination study, in which 12 patients with advanced solid tumors received CDP1 alone, and a CDP1-chemotherapy combination study, in which 20 patients with recurrent or metastatic penile cancer received CDP1 combined with the paclitaxel-ifosfamide-cisplatin regimen (TIP). Among penile cancer patients receiving the combination therapy, the objective response rate was 74%, tumor downstaging enabled surgery in seven patients (35%), and the median progression-free survival was 6.9 months. In conclusion, the combination of an anti-EGFR monoclonal antibody and chemotherapy was well tolerated and showed potential efficacy in penile cancer, supporting further investigation.

P1, N=32, Completed, Dragonboat Biopharmaceutical Company Limited | Unknown status --> Completed