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This is a multicenter, open-label Phase II study, aimed at exploring the preliminary efficacy and safety of ZG006 in patients with advanced metastatic NEPC who have previously failed standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part2 | Experimental | Participants will receive the RP2D identified in Part 1 of the study. |
|
| Part 1 | Experimental | The preliminary efficacy and safety of ZG006 at the two determined potential Phase II recommended doses (10 mg and 30 mg) will be assessed in Participants with advanced metastatic NEPC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG006 | Biological | ZG006 will be administered as an intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Best Overall Response（mBOR） | mBOR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | Baseline to 12 months | |
| Overall Survival (OS) | Baseline to 12 months | |
| Disease Control Rate (DCR) |
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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 |
|---|---|---|---|---|---|---|
| Fudan university shanghai cancer center | Shanghai | Shanghai Municipality | China |
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| Baseline to 12 months |
| Adverse Events（AE） | Day 1 to 12 months |