Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer
Not Applicable
Not yet recruiting
- Conditions
- Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT07231445
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief Summary
This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Participants with histologically or cytologically confirmed ES-SCLC.
- Fully understand the study and voluntarily sign the informed consent form;
- Male or female 18~75 years of age;
- Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 3 months;
Exclusion Criteria
- Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1：Group A ZG006 ZG006 D1: 1 mg; D22 onward: 10 mg; Q3W；Serplulimab 4.5 mg/kg，Q3W Part 1：Group A Serplulimab ZG006 D1: 1 mg; D22 onward: 10 mg; Q3W；Serplulimab 4.5 mg/kg，Q3W Part 1：Group B ZG006 ZG006 D1: 1 mg; D22 onward: 30 mg; Q3W；Serplulimab 4.5 mg/kg，Q3W Part 1：Group B Serplulimab ZG006 D1: 1 mg; D22 onward: 30 mg; Q3W；Serplulimab 4.5 mg/kg，Q3W
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Dose-limiting toxicities (DLTs) Up to Day 28 Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Up to 2 Years
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Up to 2 Years Maximum Serum Concentration (Cmax) of ZG006 Up to 2 Years Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006 Up to 2 Years
Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital🇨🇳Shanghai, Shanghai Municipality, ChinaShun LuContact