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This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABL503 | Experimental | ABL503 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in the dose-expansion part will be re-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 |
|---|---|---|---|---|
| ABL503 | Drug | ABL503 will be administered intravenously (IV) on Day 1 and Day 15 of every 28-day cycle in the dose-escalation part. The dosing interval to be used in the dose-expansion part will be re-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 Toxicity (DLT) | From Day 1 until disease progression or Day 28, whichever came first |
| Number of subjects with AE, IrAEs, IRRs, SAEs and abnormalities in Lab | Number of subjects with Adverse Event, Immune-related Adverse Event, Infusion-related Reactions (IRRs), serious AEs, and abnormalities in lab parameters | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of subject with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juyeun Jeon | Contact | +82-31-8014-7039 | juyeun.jeon@ablbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| Pharmacokinetic (PK) of ABL503 | Serum concentrations of ABL503 will be collected and analyzed to evaluate the PK of ABL503 | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months |
| Immunogenicity of ABL503 | Incidence of anti-ABL503 antibody will be analyzed to evaluate the Immunogenicity of ABL503 | From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months |
| USC | Recruiting | Los Angeles | California | 90033 | United States |
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| UCLA | Recruiting | Santa Monica | California | 90404 | United States |
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| Sarah Cannon Research Institute at HealthONE | Recruiting | Denver | Colorado | 80218 | United States |
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| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |