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This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation study of ABL103 to evaluate the safety, tolerability, MTD (maximum tolerated dose) and/or RP2D (recommended phase 2 dose), pharmacokinetics, immunogenicity, preliminary antitumor activity of ABL103 in subjects with any progressive locally advanced(unresectable) or metastatic solid tumor who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 2 parts: a dose-escalation part and tumor-expansion part
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABL103 | Experimental | ABL103 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in tumor-expansion part will be evaluated based on the emerging safety and PK data from the dose-escalation part of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABL103 | Drug | ABL103 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in tumor-expansion part will be evaluated based on the emerging safety and PK data from the dose-escalation part of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Dose-Limiting Toxicities (DLT) | Number of subjects with Dose-Limiting Toxicities (DLT) | From Day 1 until disease progression or Day 28 |
| Number of subjects with Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and immune-related Adverse Events (irAEs) | Number of subjects with Treatment-emergent AEs, SAEs and irAEs | From Day 1 until confirmed Complete Response (CR), disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first |
| Number of subjects with Treatment-emergent Infusion related reactions (IRRs) | Number of subjects with Treatment-emergent IRRs | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first |
| Number of subjects with the changes from baseline in laboratory values | Number of subjects with the changes from baseline in laboratory values | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of ABL103 | serum concentration of ABL103 will be collected and analyzed to evaluate the PK of ABL103 | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sangmi Le | Contact | +82-31-8014-7030 | sangmi.lee@ablbio.com | |
| Jungwoo Choi | Contact | +82-31-8018-9857 | jungwoo.choi@ablbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Sangmi Lee | Clinical development team | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | Seoul | 13620 | South Korea |
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| Seoul National University Hospital | Not yet recruiting | Seoul | Seoul | 03080 | South Korea |
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| Sevrance Hospital | Recruiting | Seoul | South Korea | 03722 | South Korea |
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