ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma

NCT07038096 · tracked via the Priya Life Science China tracker

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase

Phase 1/2

Started

2025-09-23

Last updated

2026-01-05

Condition(s) studied

Small Cell Lung CancerNeuroendocrine Carcinoma

Investigational drug(s) / intervention(s)

ZG006ZG005

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

ZG005: ZG005 will be administered as an intravenous (IV) infusion.

Study summary

This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Male or female 18-70 years of age. * Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology. * Eastern Cooperative Oncology Group (ECOG) 0 to 1. * Life expectancy \> 3 months. Exclusion Criteria: * The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.

Primary outcome measure(s)

Number of Participants Who Experienced Dose-limiting Toxicity (DLT) — up to 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs) — Up to 2 years
Objective Response Rate (ORR) — Up to 2 years
The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.

Trial sites (1)

Facility	City	Region	Status
Sun Yat-sen University Cancer Center	Guanzhou	Guangdong	Recruiting

More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China

Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma Recruiting

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma. Recruiting

ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular Starting soon

Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer Recruiting

Other trials for the same condition

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ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer Recruiting

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer Recruiting

Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07038096 on ClinicalTrials.gov ↗ ← All trials in China