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Clinical Trials in China / NCT07038096
Recruiting Phase 1/2

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)

ZG006 →ZG005 →

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
No
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)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guanzhou Guangdong Recruiting

More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China

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
Study of ZGGS34 in Participants With Advanced Solid Tumors Recruiting
ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular Starting soon
Study of ZG006 in Participants With Neuroendocrine Prostate Cancer Starting soon
ZG005 Plus Etoposide and Cisplatin vs. Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma Starting soon

Other trials for the same condition

Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer Recruiting
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
A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors Starting soon
A Multi-omics Sequencing-based Model for Predicting Efficacy and Dynamic Monitoring of Treatment in Small Cell Lung Cancer Recruiting
SKB500 Combinations in Patients With Small Cell Lung Cancer Recruiting
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