Linker Information
General Information of This Linker (ID: LIN0NDOEN)
| Name |
A cleavable linker
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| Linker Type |
Unclear
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| Antibody-Linker Relation |
Cleavable
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| Structure |
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Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
JBH492 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | stable disease (SD) |
8%
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| Patients Enrolled |
Inclusion criteria for CLL patients require a confirmed diagnosis, while NHL patients must have a histologically confirmed diagnosis and be willing to undergo biopsies. Exclusion criteria apply to both groups, covering hypersensitivity to ADCs or mAbs, prior DM1/DM4 ADC treatment, corneal disorders, CNS involvement (unless treated), cardiac impairment, HIV, and active HBV/HCV (with controlled cases under antivirals eligible). Additional criteria may apply.
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| Administration Dosage |
Five dose levels of JBH492 monotherapy ranging from 0.4 to 3.6 mg/kg (intravenous administration every 3 weeks [q3W]) were tested with 3 - 7 pts enrolled per dose level.
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| Related Clinical Trial | |||||
| NCT Number | NCT04240704 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
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| Primary Endpoint |
The study evaluates the incidence and severity of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs) over 32 months, with DLTs defined as protocol-specified adverse events during the first treatment cycle. It also measures treatment interruptions, dose reductions, and dose intensity, where relative dose intensity is calculated for subjects with non-zero exposure.
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| Other Endpoint |
Key efficacy outcomes include overall response rate (ORR), best overall response (BOR), duration of response (DOR), and progression-free survival (PFS) over 32 months. Pharmacokinetic (PK) parameters cover AUClast, AUCinf, AUCtau, Cmax, Cmin, Tmax, and T1/2 for four analytes, alongside anti-JBH492 antibody incidence.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Partial Response (PR) |
16%
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| Patients Enrolled |
Inclusion criteria for CLL patients require a confirmed diagnosis, while NHL patients must have a histologically confirmed diagnosis and be willing to undergo biopsies. Exclusion criteria apply to both groups, covering hypersensitivity to ADCs or mAbs, prior DM1/DM4 ADC treatment, corneal disorders, CNS involvement (unless treated), cardiac impairment, HIV, and active HBV/HCV (with controlled cases under antivirals eligible). Additional criteria may apply.
Click to Show/Hide
|
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| Administration Dosage |
Five dose levels of JBH492 monotherapy ranging from 0.4 to 3.6 mg/kg (intravenous administration every 3 weeks [q3W]) were tested with 3 - 7 pts enrolled per dose level.
|
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| Related Clinical Trial | |||||
| NCT Number | NCT04240704 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
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| Primary Endpoint |
The study evaluates the incidence and severity of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs) over 32 months, with DLTs defined as protocol-specified adverse events during the first treatment cycle. It also measures treatment interruptions, dose reductions, and dose intensity, where relative dose intensity is calculated for subjects with non-zero exposure.
Click to Show/Hide
|
||||
| Other Endpoint |
Key efficacy outcomes include overall response rate (ORR), best overall response (BOR), duration of response (DOR), and progression-free survival (PFS) over 32 months. Pharmacokinetic (PK) parameters cover AUClast, AUCinf, AUCtau, Cmax, Cmin, Tmax, and T1/2 for four analytes, alongside anti-JBH492 antibody incidence.
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