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The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC/GEJ and advanced CLDN18.2+ PDAC.
Participants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks. |
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| Dose Level 2 | Experimental |
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| Dose Level 3 | Experimental |
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| Dose Level 4 | Experimental |
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| Dose Level 5 | Experimental |
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| Dose Level 6 | Experimental |
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| Dose Level 7 | Experimental |
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| Dose Level 8 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-3501 | Drug | Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1 | 21 days | |
| Optimal Biological Effective Dose (OBED) Based on best Overall Response Rate (ORR) | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiwon Shin | Contact | 82-2-920-8768 | jiwon_shin@donga.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA University Bundang Medical Center | Recruiting | Seongnam | Bundang | 13496 | South Korea | |
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| Experimental |
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| Dose Level 9 | Experimental |
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| Dose Level 10 | Experimental |
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| Dose Level 11 | Experimental |
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| Seoul National University Bundang Hospital |
| Recruiting |
| Seongnam |
| Bundang |
| 13620 |
| South Korea |
| Severance Hospital | Recruiting | Seoul | Seoul | 03722 | South Korea |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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