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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1:Group A | Experimental | ZG006 Q3W |
|
| Part 1:Group B | Experimental | ZG006 Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG006 | Drug | ZG006 will be administered as an IV infusion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong Zhang | Contact | 17602176888 | zhangc@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Serplulimab |
| Drug |
Serplulimab will be administered as an IV infusion. |
|
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006 |
| Up to 2 Years |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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