Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0OGZEE
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| ADC Name |
Mirzotamab clezutoclax
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| Synonyms |
mirzotamab clezutoclax; ABBV-155
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| Organization |
AbbVie (Top20 MNC) (Originator)
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
2
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| Structure |
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| Antibody Name |
Mirzotamab
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Antibody Info | ||||
| Antigen Name |
CD276 antigen (CD276); Hepatocyte growth factor receptor (MET)
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Antigen Info | ||||
| Payload Name |
clezutoclax
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Payload Info | ||||
| Therapeutic Target |
Bcl-2-like protein 1 (BCL2L1)
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Target Info | ||||
| Linker Name |
Val-Ala dipeptide linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
clezutoclax
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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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| Breast cancer |
1 Trials
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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 |
Inclusion: Solid tumor patients (Part 2a: SCLC; Part 2b: NSCLC/HR+HER2- breast cancer) with measurable disease, ECOG ≤2, prior therapy failure. Breast cancer patients must have CDK4/6 inhibitor failure; NSCLC patients require targeted therapy if actionable mutations present. Exclusion: Active CNS metastases, Grade≥2 neuropathy, unresolved toxicities, active hepatitis/HIV, significant cardiac history, or hypersensitivity to study drug components. Taxane-exposed patients require 2-month washout.
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| Administration Dosage |
Participants will be administered ABBV-155 (various doses).
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| Related Clinical Trial | |||||
| NCT Number | NCT03595059 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 First-in-Human Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include MTD/RPTD determination during dose escalation (21-day evaluation) and ORR assessment (RECIST 1.1) with 2-6 month follow-up in expansion phases.
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| Other Endpoint |
Secondary objectives comprise AE monitoring (12 months), efficacy measures (DOR/CR/PFS/OS), PK parameters (Cmax/Tmax/AUCt/AUCinf/t1/2 over 48 days), and cardiac safety (QTcF changes).
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References