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Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Summary
The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.
Official title: A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2024-05-30
Completion Date
2026-08
Last Updated
2024-06-14
Healthy Volunteers
No
Conditions
Interventions
ZG005
ZG005 for dose escalations are set as 10mg/kg, 20mg/kg, and the other doses after discussion. intravenous infusion, once every 3 weeks. ZG005 for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
Etoposide
IV infusion
Cisplatin
IV infusion
Placebo
0.9% Sodium Chloride Injection
Locations (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China