A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Fully understand the study and voluntarily sign the informed consent form.
• Male or female 18-70 years of age.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• Histologically confirmed recurrent or metastatic neuroendocrine carcinoma
• Life expectancy ≥ 3 months.
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Cheng Wei
weic@zelgen.com
+8651257309965
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2026-08
Participants
Target number of participants: 93
Treatments
Experimental: Part 1: Dose Escalation
Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.
Experimental: Part 2: Dose Expansion
Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.
Related Therapeutic Areas
Sponsors
Leads: Suzhou Zelgen Biopharmaceuticals Co.,Ltd