Payload Information
General Information of This Payload (ID: PAY0AXWOO)
| Name |
α-amanitin
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| Target | RNA polymerase II | |||||
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
opelkibart elmanitin [Phase 1/2 (discontinued)]
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).
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| Administration Dosage |
MGTA-117 will be administered as an IV infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT05223699 | Phase 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)
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| 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.
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References