Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0MRJEG
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| ADC Name |
REGN5093-M114
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| Synonyms |
REGN5093-M114
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| Organization |
Regeneron Pharmaceuticals (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
3.2
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| Structure |
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| Antibody Name |
REGN5093
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Antibody Info | ||||
| Antigen Name |
Hepatocyte growth factor receptor (MET); Macrophage-stimulating protein receptor (MST1R)
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Antigen Info | ||||
| Payload Name |
Maytansine derivative M24
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
SC-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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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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| Lung cancer |
1 Trials
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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 |
Eligible: Advanced NSCLC (no standard options), ECOG 0-1, MET overexpression (fresh/archival biopsy ≤6 months old), measurable lesion (s) (expansion), adequate organ function. Excluded: Recent systemic therapy (<2 weeks/5 half-lives), unresolved toxicities (>grade 1), active CNS disease, uncontrolled infections (HIV/HBV/HCV), or concurrent malignancy. Prior irradiation requires documented progression in irradiated lesions.
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| Administration Dosage |
Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.
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| Related Clinical Trial | |||||
| NCT Number | NCT04982224 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients With MET Overexpressing Advanced Cancer | ||||
| Primary Endpoint |
Phase 1 dose escalation will assess safety through DLTs (28-day window), TEAEs, SAEs, treatment discontinuations, deaths, and CTCAE grade 3+ lab abnormalities over ~2 years. Pharmacokinetics include serum concentrations of REGN5093-M114 (total/conjugated), plasma M24 levels, and cemiplimab concentrations (Cohort C). Phase 2 expands ORR evaluation.
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| Other Endpoint |
Efficacy/Safety (both phases): ORR, TEAEs, SAEs, treatment-limiting toxicities, lab abnormalities, PK of REGN5093-M114/M24/cemiplimab (Cohort C), and ADA incidence/titer against cemiplimab/REGN5093-M114. Tumor response endpoints (DOR, DCR, TTR, PFS, OS) are tracked over 2 years.
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References