Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0EMENQ
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| ADC Name |
S227928
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| Synonyms |
S227928
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| Organization |
Servier (Originator)
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| Drug Status |
Phase 1/2 (discontinued)
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| Antibody Name |
Anti-CD74 antibody
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Antibody Info | ||||
| Antigen Name |
HLA class II histocompatibility antigen gamma chain (CD74)
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Antigen Info | ||||
| Payload Name |
S64315 (MIK665)
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Payload Info | ||||
| Therapeutic Target |
Induced myeloid leukemia cell differentiation protein Mcl-1 (MCL1)
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Target Info | ||||
| Linker Name |
Val-Cit-(PEG24) linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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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 | ||
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| Acute myeloid leukaemia |
1 Trials
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| Chronic myeloid leukemia |
1 Trials
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| Myelodysplastic syndrome |
1 Trials
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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 had R/R AML/MDS-AML/CMML (WHO/ICC 2022), ECOG ≤2, leukocytes <10×10<sup>9</sup>/L (hydroxycarbamide permitted), and adequate renal/hepatic function. Exclusions included pregnancy, uncontrolled infections (HBV/HCV/HIV under strict criteria), QTc prolongation (>450ms males/>470ms females), active CNS involvement, recent allogeneic SCT (<3 months), dual CYP3A4/CYP2C8 inhibitors (Arm A), or P-gp/BCRP interactions (Arms B/expansion). Prior anticancer therapy required a 2-week/5-half-life washout (28 days for biologics).
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06563804 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | Phase 1/2 Clinical Trial of S227928, an Anti-CD74 Antibody-Drug Conjugate Targeting MCL-1, as a Single Agent and in Combination With Venetoclax in Patients With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML) | ||||
| Primary Endpoint |
The dose-escalation phase evaluated DLTs during Cycle 1 (28 days) and tracked AE/SAE incidence over ~3.5 years, including dose adjustments/discontinuations. CR was assessed in dose expansion (~4 years).
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| Other Endpoint |
PK parameters (Cmax, Tmax, AUC, plasma profiles) for S227928 components (total mAb, unconjugated S64315) and venetoclax (Arm B/dose expansion) were analyzed over ~3.5 years. Efficacy outcomes (CR/CRi/CRh/MLFS/PR/ORR/DOR/PFS/OS/EFS) and transfusion independence were assessed in R/R AML/MDS-AML/CMML patients over ~4 years, with cohort-specific analyses (e.g., CRL/HI for CMML). ADA against S227928 was monitored.
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References