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A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma

NCT07595913 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Neuroendocrine Carcinoma

Interventions

BIOLOGICAL

ZG006

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

DRUG

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.

Sponsors & Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jason Wu · Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595913 on ClinicalTrials.gov