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This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A : APX-343A | Experimental | Part A is a dose-escalation study of APX-343A monotherapy in subjects with advanced solid tumors. |
|
| Part B | Experimental | Part B is a dose-escalation study of APX-343A in combination with pembrolizumab, targeting subjects with advanced solid tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APX-343A | Drug | Oral administration twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability and to determine the MTD and/or RP2D of APX-343A monotherapy and in combination with pembrolizumab | Number and severity of TEAEs according to NCI-CTCAE v5.0 | From enrollment to 90 days after End Of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of APX-343A | To characterize the PK of APX 343A monotherapy | From enrollment to 3 weeks |
| AUC of APX-343A | To characterize the PK of APX-343A monotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Center, Clinical Center | Contact | +82-31-365-3693 | cd@aptabio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
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| Pembrolizumab |
| Drug |
intravenous [IV] |
|
| From enrollment to 3 weeks |
| Tmax of APX-343A | To characterize the PK of APX-343A monotherapy | From enrollment to 3 weeks |
| t1/2 of APX-343A | To characterize the PK of APX-343A monotherapy | From enrollment to 3 weeks |
| CL of APX-343A | To characterize the PK of APX-343A monotherapy | From enrollment to 3 weeks |
| Response rate according to RECIST v1.1 and iRECIST | To evaluate preliminary efficacy of APX-343A monotherapy and in combination with pembrolizumab | Through study completion, an average of 1 year |
| Gangnam Severance Hospital, Yonsei University Health System | Recruiting | Seoul | South Korea |
|
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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