ArticleCancer medicine2025
Preclinical Development and Phase I Study of ZSYY001, a Polymeric Micellar Paclitaxel for Advanced Solid Tumor.
Article in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Paclitaxel Nanomedicines: Molecular Mechanisms of Drug Resistance, Tumor Microenvironment-Responsive Delivery, and Translational Challenges.International journal of molecular sciences · 2026Review
- From Screening to a Nanotechnological Platform: Cannabidiol-Chemotherapy Co-Loaded Lipid Nanocapsules for Glioblastoma Multiforme Treatment.Pharmaceutics · 2025Article
- Preclinical Development and Phase I Study of ZSYY001, a Polymeric Micellar Paclitaxel for Advanced Solid Tumor.Cancer medicine · 2025Article
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Authors and funding
11 authors.
Funding
Abstract
purposeA novel paclitaxel delivery system has the potential to avoid the side effects associated with Cremophor EL and thus enhance therapeutic efficacy. Here, we report the results of a preclinical and phase I clinical study investigating ZSYY001, a nanoparticle formulation of polymeric micellar paclitaxel (PM-paclitaxel).
methodsIn preclinical studies, A549, MDA-MB-231, and SKOV3 xenograft tumor models were developed. Various concentrations of ZSYY001 were administered, and tumor growth and body weight were measured. Sprague-Dawley (SD) rats and Beagle dogs were used to evaluate the toxicity. In the phase I study, a dose-escalation study using a 3 + 3 design was conducted in patients with solid tumors. The PM-paclitaxel dose was escalated from 175 mg/m
resultsPreclinical studies showed that ZSYY001 significantly inhibited tumor growth without causing weight loss. In the phase I study, all patients were evaluable for toxicity and pharmacokinetic analysis, and 18 patients were evaluable for tumor response. Acute hypersensitivity reactions were not observed. Anemia and hair loss were the most common toxicities. Dose-limiting toxicity events were not observed at any dose levels. Dose escalation to 390 mg/m
conclusionsZSYY001 was safe and well tolerated without additional toxicity and exhibited desirable antitumor activity, making it a promising treatment.
trial registrationCTR20210347.
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