Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZG005, Etoposide, Cisplatin, Placebo.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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
- Biological ZG005
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. - Drug Etoposide
IV infusion - Drug Cisplatin
IV infusion - Drug Placebo
0.9% Sodium Chloride Injection
Primary outcome measures
- Dose Limiting Toxicity (DLT) [Time frame: Up to 2 years]
- Objective Response Rate (ORR) [Time frame: Up to 2 years]
- Adverse Event (AE) [Time frame: Up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT06372626 · ZG005-004