Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0EPYFC)
| ADC Name |
SAR428926
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| Synonyms |
SAR428926
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| Organization |
ImmunoGen (Top20 MNC) (Originator) (No Rights);Sanofi (Top20 MNC)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
~4
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| Structure |
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| Antibody Name |
Anti-LAMP-1 antibody
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Antibody Info | ||||
| Antigen Name |
Lysosome-associated membrane glycoprotein 1 (LAMP1)
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Antigen Info | ||||
| Payload Name |
DM4
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
N-succinimidyl 4-(2-pyridyldithio) butanoate (SPDB)
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
ravtansine
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Disease Name | Phase 1 | Phase 2 | Phase 3 | Approved |
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| Gastric cancer | ||||
| Colorectal cancer | ||||
| Lung cancer | ||||
| Breast cancer | ||||
| Ovarian cancer | ||||
| Prostate cancer |
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 |
Eligibility requires advanced solid tumors without standard options, with HER2- cancers (escalation) or SAR428926-target-antigen+ tumors (expansion, including TNBC/prostate/CRC/ovarian/NSCLC). Measurable lesions (RECIST v1.1) and biopsy-accessible lesions (expansion, NSCLC exempt) are mandatory. Exclusions cover prior DM1/DM4-ADC therapy, active HBV/HCV/HIV, corneal/neuropathy/cardiac issues (LVEF<50%), CYP3A inhibitor use, contact lens dependence, inadequate organ function, and contraindications to ocular medications (e.g., glaucoma). Reproductive-age participants must comply with pregnancy prevention protocols.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT02575781 | Clinical Status | PHASE1 | ||
| Clinical Description | A First-in-human Phase 1 Dose Escalation Study of SAR428926 in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
The safety evaluation focuses on dose-limiting adverse events (4-week window, escalation cohort) and corneal AE impact (8-week window). Efficacy in the expansion cohort involves RECIST v1.1-assessed ORR with bimonthly tumor imaging until progression or 36 months maximum duration.
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| Other Endpoint |
Long-term AE monitoring spans 3 years, alongside PK assessments (Cmax, tmax, Ctrough, AUC0-14, CL, and accumulation ratios) at 2-month intervals. Corneal event documentation (12 weeks) includes preventive measure analysis, while preliminary tumor response (escalation, 2 months) supplements RECIST v1.1 tracking.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02575781 | Clinical Status | Phase 1 | ||
| Clinical Description | A first-in-human phase 1 dose escalation study of SAR428926 in patients with advanced solid tumors. | ||||
References