Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0UAJZK)
| ADC Name |
opelkibart elmanitin
|
|||||
|---|---|---|---|---|---|---|
| Synonyms |
opelkibart elmanitin; C200; MGTA-117
Click to Show/Hide
|
|||||
| Organization |
Magenta Therapeutics (Originator);Heidelberg Pharma (Originator) (No Rights)
|
|||||
| Drug Status |
Phase 1/2 (discontinued)
|
|||||
| Drug-to-Antibody Ratio |
2
|
|||||
| Antibody Name |
Opelkibart
|
Antibody Info | ||||
| Antigen Name |
Mast/stem cell growth factor receptor Kit (KIT)
|
Antigen Info | ||||
| Payload Name |
α-amanitin
|
Payload Info | ||||
| Payload Target |
RNA polymerase II
|
Target Info | ||||
| Linker Name |
Undisclosed
|
|||||
| Conjugate Type |
Undisclosed
|
|||||
| Combination Type |
elmanitin
|
|||||
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
General Information of The Activity Data Related to This ADC
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 |
Key inclusion: WHO-defined R/R AML/MDS-EB patients (treatment failure/refractory or MRD+ in CR); CD117+ confirmed; identified HSC donor; ECOG ≤2; adequate hepatic/renal/cardiac function (ALT/AST/ALP ≤2xULN, bilirubin ≤1.5xULN, CrCl ≥60mL/min, LVEF ≥40% or NYHA I-II).
|
||||
| Administration Dosage |
MGTA-117 will be administered as an IV infusion
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05223699 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I/II, Dose-Escalation Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB) | ||||
| Primary Endpoint |
Primary endpoints include TEAE-related discontinuation rate, ≥Grade 3 lab abnormalities (CTCAE v5.0), vital signs/ECG/lab parameter changes, MGTA-117 PK profile (AUC/Cmax/Tmax/t1/2/plasma concentration), and minimum safe/effective dose (CD117 receptor occupancy at Day 7 and DLT incidence at Day 21), all assessed within 21 days.
|
||||
References