Heavy! China's first "PEG small molecule anti-tumor drug" officially launched clinical
On January 14, 2019, China's first "PEG small molecule anti-tumor drug" project kick-off meeting was successfully held, which marked the official launch of the first domestic PEG small molecule anti-tumor drug clinical trial. This project brings new hope for the treatment of solid tumors.
Clinical trial purpose
MAIN OBJECTIVE: To evaluate the safety and tolerability of polyethylene glycol irinotecan for injection in patients with malignant solid tumors; and to determine its dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
The secondary objective was to examine the pharmacokinetic properties of patients with malignant solid tumors and obtain pharmacokinetic parameters; to observe the initial efficacy of polyethylene glycol irinotecan for injection, and to recommend doses for subsequent clinical trials. The method of medicine provides the basis.
Most small molecule anti-tumor drugs have poor water solubility, short half-life in vivo, and low bioavailability. Modified by polyethylene glycol (PEG) can significantly improve the water solubility of the drug, prolong the half-life in the body, and improve by enhanced penetration and retention effects. Passive targeting of tumor tissue.
As a development company, Keykai Technology successfully completed the development of the first small molecule anti-tumor drug in China. After PEG bonding, it improved the efficacy, reduced the side effects, increased the anti-tumor spectrum and reduced the number of administrations.
Guanqin Pharmaceutical, as a contract research organization specializing in drug development project management services, provides project management for pre-clinical registration and phase I clinical trials.