At a glance
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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.
In Brief
A Phase 2 clinical trial evaluating ZG005, Etoposide, and 2 other interventions for Neuroendocrine Carcinoma. Currently recruiting, targeting 93 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
IV infusion
IV infusion
0.9% Sodium Chloride Injection