Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
Phase 1
Recruiting
- Conditions
- Neuroendocrine Carcinoma
- Interventions
- Registration Number
- NCT06372626
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 93
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation ZG005 Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin. Part 2: Dose Expansion ZG005 Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin. Part 2: Dose Expansion Placebo Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin. Part 1: Dose Escalation Cisplatin Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin. Part 1: Dose Escalation Etoposide Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin. Part 2: Dose Expansion Etoposide Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin. Part 2: Dose Expansion Cisplatin Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.
- Primary Outcome Measures
Name Time Method Adverse Event (AE) Up to 2 years Number of participants with adverse events that are related to treatment
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China