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This is an open-label, multicenter Phase 1 study of DEC003M, in patients with advanced stage prostate cancer. The study consists of a dose-escalation phase to determine the dose for expansion, followed by a dose-expansion phase to evaluate preliminary antitumor activity, safety, and pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | DEC003M-001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEC003M | Drug | Once every 3 weeks (Q3W) with a cycle length of 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Screening up to study completion, an average of 1 year. | |
| Dose-limiting toxicity (DLT) | 3 weeks | |
| Recommended Dose for Expansion (RDE) | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Up to 24 months | |
| PSA response rate | Up to 24 months | |
| Radiographic Progression-Free Survival (rPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengyu Shi | Contact | 86-0571-56050590 | Shipengyu@dacbiotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
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| Up to 24 months |
| overall survival (OS) | Up to 36 months |
| The Third People's Hospital of Chengdu | Chengdu | Sichuan | 610095 | China |
|
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 311121 | China |
|
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
|