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

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study ID
NCT07595913
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ZG006 — BIOLOGICAL
    ZG006 will be administered as an intravenous (IV) infusion.
  • 5-fluorouracil, Calcium folinate and Irinotecan — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test Group
    ZG006 Q2W
  • Active Comparator: Control Group
    Investigator-selected chemotherapy (such as FOLFIRI regimen)

Primary Outcome Measure

Overall Survival（OS） [ Time Frame: up to approximately 4 years ]

Central Contacts

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