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.
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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
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.
Parallel
ZG005
Biological/VaccineZG005 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.
Etoposide
DrugIV infusion
Cisplatin
DrugIV infusion
Placebo
Drug0.9% Sodium Chloride Injection
Dose Limiting Toxicity (DLT)
Objective Response Rate (ORR)
ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented
Adverse Event (AE)
Number of participants with adverse events that are related to treatment
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