RecruitingPhase 1Phase 2NCT07038096

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

A Phase Ib/II Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

350 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria1

  • The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.

Interventions

DRUGZG006

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

DRUGZG005

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


Locations(1)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

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NCT07038096


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