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This is a first-in-human (FIH) phase 1 open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors. This study included 2 parts; a dose-escalation part and a dose expansion part.
This is consisted with dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABL501 | Experimental | ABL501 will be administered biweekly of every 28-day cycle in the dose-escalation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABL501 | Drug | ABL501 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with dose-limiting toxicities (DLT) | Number of subject with dose-limiting toxicities (DLT) | from Day 1 until Day 28 |
| Number of subjects who experience with TEAEs, SAEs, irAEs and IRRs | Number of subjects who experience with Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), immune-related adverse events (irAEs) and infusion related reactions (IRRs) | From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months |
| Number of subjects who experience with treatment-related TEAEs, SAEs, irAEs and IRRs | Number of subjects who experience with treatment-related Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), immune-related adverse events (irAEs) and infusion related reactions (IRRs) | From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months |
| Number of subjects who experience with clinically significant changes in laboratory values | Number of subjects who experience with clinically significant changes in laboratory values | From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of ABL501 | serum concentration of ABL501 will be collected and analyzed to evaluate the PK of ABL501 | From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sangmi Lee | Clinical development team | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seoul | 03080 | South Korea | |||
| Severance Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35526096 | Derived | Sung E, Ko M, Won JY, Jo Y, Park E, Kim H, Choi E, Jung UJ, Jeon J, Kim Y, Ahn H, Choi DS, Choi S, Hong Y, Park H, Lee H, Son YG, Park K, Won J, Oh SJ, Lee S, Kim KP, Yoo C, Song HK, Jin HS, Jung J, Park Y. LAG-3xPD-L1 bispecific antibody potentiates antitumor responses of T cells through dendritic cell activation. Mol Ther. 2022 Aug 3;30(8):2800-2816. doi: 10.1016/j.ymthe.2022.05.003. Epub 2022 May 6. |
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Drug: ABL501
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|
Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 |
| From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months |
| number of subject with anti-drug antibodies (ADAs) | Incidence of anti-drug antibodies (ADAs) will be analyzed to evaluate the immunogenicity of ABL501 | From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months |
| Seoul |
| 03722 |
| South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| ID | Term |
|---|---|
| D018033 | Antibodies, Bispecific |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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