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This is a multicenter, open-label phase I/II study, divided into 2 parts:
Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.
Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg. |
|
| Dose Expansion | Experimental | Participants will receive the RP2D identified in Dose Escalation Study . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG006 | Biological | ZG006 will be administered as an intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 | Up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shangdi Ning | Contact | +86-0512-57309965 | ningsd@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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