CI

At a glance

ClinicalIndex Comparison Record
Phase 3Not Yet Recruiting· 240 target
Drug / intervention
ZG006 +1 morebiological
Likely dose
5-fluorouracil, Calcium folinate and Irinotecan 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07595913
NCT07595913Phase 3Not Yet Recruiting

A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma

Suzhou Zelgen Biopharmaceuticals Co.,Ltd·interventional·Posted May 19, 2026·Updated May 19, 2026

In Brief

A Phase 3 clinical trial evaluating ZG006 and 5-fluorouracil, Calcium folinate and Irinotecan for Neuroendocrine Carcinoma. Not yet recruiting, targeting 240 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3Not Yet Recruiting
202720282029
First PostedMay 19, 2026
Enrollment StartJul 1, 2026
Primary CompletionJun 1, 2028
Study CompletionDec 1, 2028
TodayJul 1, 2026
Enrollment to primary: 1.9 yearsPosted 1 month agoPrimary completion in 1.9 years

Interventions

ZG006biological

ZG006 will be administered as an intravenous (IV) infusion.

5-fluorouracil, Calcium folinate and Irinotecandrug

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.