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A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Summary
This Phase III, multicenter, randomized, open-label, controlled study is designed to assess the efficacy and safety of ZG006 versus investigator-selected chemotherapy in participants with DLL3-positive advanced neuroendocrine carcinoma who have received prior systemic therapy.
Official title: A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-07
Completion Date
2028-12
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
ZG006
ZG006 will be administered as an intravenous (IV) infusion.
5-fluorouracil, Calcium folinate and Irinotecan
Irinotecan 180 mg/m\^2, Calcium folinate 400 mg/m\^2, 5-Fluorouracil: 400 mg/m\^2 by intravenous infusion on Day 1; 5-Fluorouracil: 2400 mg/m\^2 by continuous intravenous infusion over 46 to 48 hours， once two weeks.
Locations (1)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China