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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-G16 | Other Identifier | Merck Sharp & Dohme LLC | |
| MK-3475-G16 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABL103 (DL1) + pembrolizumab | Experimental | Safety Lead-in Part 1 |
|
| ABL103 (DL2-1) + pembrolizumab + taxane | Experimental | Safety Lead-in Part 2 |
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| ABL103 (DL2) + pembrolizumab + taxane | Experimental | Safety Lead-in Part 2 |
|
| Group 1) ABL103 + pembrolizumab + taxane | Experimental | Dose-expansion Part |
|
| Group 2) ABL103 + pembrolizumab + taxane | Experimental | Dose-expansion Part |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABL103 | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) | Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2) | |
| Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Serious AEs (SAEs), and Infusion-Related Reactions (IRRs) | From baseline through study completion, an average of 12 months | |
| Recommended Dose for Expansion (RDE) Determination | From baseline through study completion, an average of 12 months | |
| Objective Response Rate (ORR) | Up to approximately 30 months | |
| Disease Control Rate (DCR) | Up to approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Objective Response Rate (ORR) | Up to approximately 30 months | |
| Preliminary Disease Control Rate (DCR) | Up to approximately 30 months | |
| Incidence of Anti-Drug Antibodies (ADA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dayoung Ok | Contact | +82-2-3456-7300 | dayoung.ok@ablbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Sangmi Lee | ABL Bio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Cleveland Medical Center | Not yet recruiting | Cleveland | Ohio | 44106 | United States | |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C080625 | taxane |
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Dose escalation and Dose expansion
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| KEYTRUDA® (pembrolizumab) | Drug | IV infusion |
|
| Taxane | Drug | IV infusion |
|
| From baseline through study completion, an average of 12 months |
| PASO Medical |
| Not yet recruiting |
| Frankston |
| Victoria |
| 3199 |
| Australia |
| Seoul National University Bundang Hospital | Recruiting | Seongnam | 13620 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Asan Medical Center | Not yet recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Not yet recruiting | Seoul | 06351 | South Korea |