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

Zelgen Biopharmaceuticals

Status and phase: Begins enrollment this month; Phase 3

Conditions: Neuroendocrine Carcinoma

Treatments: Drug: 5-fluorouracil, Calcium folinate and Irinotecan; Biological: ZG006

Study type: Interventional

Funder types: Industry

Identifiers

NCT07595913

ZG006-009

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has provided written informed consent voluntarily after being fully informed about the study.
• Male or female, aged 18 to 75 years (inclusive) at the time of informed consent signing.
• Histologically or cytologically confirmed advanced neuroendocrine carcinoma (NEC); small cell lung cancer (SCLC) and combined SCLC are excluded. Additionally, the Participants with DLL3-positive NEC who have received prior systemic therapy (second-line and above)..

Exclusion criteria

• Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Test Group

Experimental group

Description:

ZG006 Q2W

Treatment:

Biological: ZG006

Control Group

Active Comparator group

Description:

Investigator-selected chemotherapy (such as FOLFIRI regimen)

Treatment:

Drug: 5-fluorouracil, Calcium folinate and Irinotecan