BC001 (cetuximab biosimilar) / Dragon Boat Biopharmaceutical - LARVOL DELTA

A Preliminary Clinical Study on the Pharmacokinetics and Safety of CDP1 in Patients With Advanced CRC or HNSCC (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Dragonboat Biopharmaceutical Company Limited | Unknown status ➔ Completed

Trial completion • Colorectal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CUX1

An Exploratory Clinical Study of LDP Combined With CDP1 in Patients With Advanced Malignant Tumor (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Dragonboat Biopharmaceutical Company Limited | Recruiting ➔ Completed | N=130 ➔ 12

Enrollment change • Trial completion • Oncology • Solid Tumor

Clinical Trial to Evaluate Pharmacokinetics,Safety and Immunogenicity of Single Injection of CDP1 to Healthy Volunteers Compared to Erbitux (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Dragonboat Biopharmaceutical Company Limited | Unknown status ➔ Completed

Trial completion • CUX1

Anti-epidermal growth factor receptor monoclonal antibody combined with chemotherapy in penile cancer: A prospective, multicenter, phase 1 study. (PubMed, Int J Cancer) - "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."

Journal • P1 data • Genito-urinary Cancer • Hematological Disorders • Oncology • Penile Cancer • Solid Tumor • CUX1 • EGFR

Phase I Clinical Trial of CDP1 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Dragonboat Biopharmaceutical Company Limited | Unknown status ➔ Completed

Metastases • Trial completion • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRAF • RAS

An Exploratory Clinical Study of LDP Combined With CDP1 in Patients With Advanced Malignant Tumor (clinicaltrials.gov) - P1; N=130; Recruiting; Sponsor: Dragonboat Biopharmaceutical Company Limited

Clinical • New P1 trial • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

A Preliminary Clinical Study on the Pharmacokinetics and Safety of CDP1 in Patients With Advanced CRC or HNSCC (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: Dragonboat Biopharmaceutical Company Limited; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Phase I Clinical Trial of CDP1 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Dragonboat Biopharmaceutical Company Limited

Clinical • New P1 trial