Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0EZVZS
|
|||||
|---|---|---|---|---|---|---|
| ADC Name |
BYON-4413
|
|||||
| Synonyms |
BYON-4413; BYON4413
Click to Show/Hide
|
|||||
| Organization |
Byondis (Originator)
|
|||||
| Drug Status |
Phase 1
|
|||||
| Drug-to-Antibody Ratio |
1.9
|
|||||
| Structure |
|
|||||
| Antibody Name |
Anti-CD123 IgG1 mAb
|
Antibody Info | ||||
| Antigen Name |
Interleukin-3 receptor subunit alpha (IL3RA)
|
Antigen Info | ||||
| Payload Name |
Seco-DUBA
|
Payload Info | ||||
| Therapeutic Target |
Human deoxyribonucleic acid (hDNA)
|
Target Info | ||||
| Linker Name |
Mal-PEG2-Val-Cit-PABA-Cyclization Spacer
|
Linker Info | ||||
| Conjugate Type |
Reactive Cysteines
|
|||||
| Combination Type |
duocarmazine
|
|||||
The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
|---|---|---|---|---|---|---|---|---|---|
| Acute myeloid leukaemia |
1 Trials
|
||||||||
| Myelodysplastic syndrome |
1 Trials
|
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients have R/R AML or high-blast MDS post-HMA failure (≥3 cycles) with ECOG 0-2; exclusions comprise prior CD123 therapy, recent HSCT (<100 days), unresolved toxicities (>CTCAE Gr1), APL/CNS involvement, active hepatitis, or significant cardiovascular/pulmonary/ocular comorbidities.
|
||||
| Administration Dosage |
BYON4413 will be administered by IV infusion.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT06359002 | Clinical Status | PHASE1 | ||
| Clinical Description | A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms. | ||||
| Primary Endpoint |
The study evaluates dose-limiting toxicities during initial 21 days and assesses composite complete remission rates (CR+CRh+CRi per ELN 2022) up to 24 months in dose escalation and expansion phases.
|
||||
| Other Endpoint |
Safety parameters include AE monitoring and dose modifications for 24 months, while pharmacokinetics (Cmax, Tmax, AUC) and immunogenicity (anti-drug antibodies) are tracked alongside efficacy measures (ORR, DoR, RFS, EFS, OS) using ELN 2022 criteria throughout the study period.
|
||||
References