Preclinical Development and Phase I Study of ZSYY001, a Polymeric Micellar Paclitaxel for Advanced Solid Tumor

The study investigated ZSYY001, a polymeric micellar paclitaxel formulation, in preclinical and phase I trials for advanced solid tumors. Preclinical tests on xenograft models showed significant tumor growth inhibition without weight loss. In the phase I trial, involving 18 patients, ZSYY001 was administered at doses up to 390 mg/m² without premedication, and no dose-limiting toxicities were observed. Common side effects included anemia and hair loss, but no acute hypersensitivity reactions occurred. The study found two partial responses and seven cases of stable disease, indicating promising antitumor activity. ZSYY001 was deemed safe, well-tolerated, and exhibited non-linear pharmacokinetics, suggesting it as a potential treatment option.