Neuroendocrine Carcinoma
Conditions
Brief 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.
Interventions
BIOLOGICALZG005
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.
DRUGEtoposide
IV infusion
DRUGCisplatin
IV infusion
DRUGPlacebo
0.9% Sodium Chloride Injection
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Histologically confirmed recurrent or metastatic neuroendocrine carcinoma * Life expectancy ≥ 3 months.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Up to 2 years | — |
| Objective Response Rate (ORR) | Up to 2 years | 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) | Up to 2 years | Number of participants with adverse events that are related to treatment |
Countries
China
Contacts
Primary ContactCheng Wei
Outcome results
None listed