Antibody Information
General Information of This Antibody (ID: ANTI0ZOSEH)
| Antibody Name | huMy9-6 |
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| Antigen Name | CD33 |
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
AVE9633 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Inclusion: CD33+ relapsed/refractory AML patients (no curative options) with ECOG 0-2. Exclusion: Recent gemtuzumab ozogamicin/allogenic transplant (≤6 months), anticancer therapy ≤3 weeks (hydroxyurea/leukophoresis allowed), prior AVE9633 exposure, organ dysfunction, comorbidities affecting safety, pregnancy/lactation, or inadequate contraception.
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| Administration Dosage |
AVE9633 was administered at increasing doses using three treatment schedules, as outlined in Table 1. In the initial trial (so-called "Day 1 study") 22 patients received 15 to 260 mg/m2 on day 1 of a 21-day cycle. Following the completion of the first dose levels, two other trials were initiated; 20 patients received 30 to 150 mg/m2 on day 1 and day 8 of a 28-day cycle (Day 1/8 study) and 12 patients received 30 to 90 mg/m2 on day 1, day 4 and day 7 of a 28-day cycle (Day 1/4/7 study).
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| Related Clinical Trial | |||||
| NCT Number | NCT00543972 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)
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| Primary Endpoint |
The primary outcome is incidence of Dose Limiting Toxicities (DLTs) across tested dose levels during the study period.
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| Other Endpoint |
Efficacy endpoints include Complete Remission (CR), CR with incomplete platelet recovery (CRp), Partial Remission (PR) rates, time to/duration of CR, and peripheral blast clearance. Safety is assessed through Adverse Events (AEs).
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References