A Preliminary Clinical Study on the Pharmacokinetics and Safety of CDP1 in Patients With Advanced CRC or HNSCC
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
Colorectal cancer (CRC) is one of the most common human malignant tumors. The incidence and
mortality of colorectal cancer in our country are on the rise. Surgery-based, combined with
chemotherapy, radiotherapy comprehensive treatment, is the main treatment of colorectal
cancer. Surgical resection has been recognized as the primary treatment of colorectal cancer.
However, due to the majority of patients already advanced at the time of diagnosis, some
difficulties are brought to radical surgery. Therefore, the importance of chemotherapy for
colorectal cancer gradually been clinically recognized, But rarely survive more than 18
months." In addition to chemotherapy, there is now a more ideal model of cancer treatment-
molecular targeted therapies, including monoclonal antibody drugs such as cetuximab, as well
as small molecule tyrosine kinases Inhibitors gefitinib and so on. Molecular targeted drugs
make use of the difference in molecular biology between tumor cells and normal cells.
Targeting drugs to tumor cells and inhibiting the growth and proliferation of the cells can
achieve the therapeutic effect, which has the advantages of high specificity and low adverse
reaction. The bio-targeted drug cetuximab is the first drug approved to marketed as an
epidermal growth factor receptor (EGFR)-targeting immunoglobulin 1（IgG1）monoclonal antibody.
Cetuximab, either monotherapy or combined radiotherapy and chemotherapy, can exert excellent
anti-tumor activity in EGFR-positive malignant tumors and can significantly enhance the
efficacy of radiotherapy and chemotherapy.
Reference to cetuximab injection, guilin sanjin Co., Ltd. and dragonboat Co., Ltd. jointly
developed a recombinant anti-EGFR human mouse chimeric monoclonal antibody (R & D code:
CDP1).The primary structure of CDP1 is exactly the same with cetuximab, the higher structure
and Physical and chemical properties and cetuximab are highly similar. Pharmacodynamic
activity in vivo and in vitro, pharmacokinetic characteristics and toxicological reactions
are also similar to cetuximab. CDP1 selected with cetuximab consistent formulations,
prescriptions, specifications.
CDP1 was approved by China Food and Drug Administration (No. 2016L06884) in August 2016 for
clinical studies. According to the contents of the document and guidelines for biological
analogs, the clinical pharmacokinetic and clinical effectiveness comparison tests of CDP1 and
the safety and immunogenicity assessment are planned.