Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
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.
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
93 participants
May 30, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria3
- Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases;
- Any other malignancy within 5 years.
- participants were deemed unsuitable for participating in the study by the investigator for any reasons.
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Interventions
ZG005 for dose escalations are set as 10mg/kg, 20mg/kg, and the other doses after discussion. intravenous infusion, once every 3 weeks. ZG005 for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
IV infusion
IV infusion
0.9% Sodium Chloride Injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06372626