General Information of This Antibody-drug Conjugate (ID: DRG0OGZEE)
ADC Name
Mirzotamab clezutoclax
Synonyms
mirzotamab clezutoclax; ABBV-155
   Click to Show/Hide
Organization
AbbVie (Top20 MNC) (Originator)
Drug Status
Phase 1
Drug-to-Antibody Ratio
2
Antibody Name
Mirzotamab
 Antibody Info 
Antigen Name
CD276 antigen (CD276)
 Antigen Info 
Payload Name
clezutoclax
 Payload Info 
Payload Target
Bcl-2-like protein 1 (BCL2L1)
 Target Info 
Linker Name
Val-Ala dipeptide linker
 Linker Info 
Conjugate Type
Random Cysteines
Combination Type
clezutoclax
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
Lung cancer
1 Trials
Clinical trial identifier
TWCT00003745; NCT03595059; jRCT2080225314; JapicCTI-205410; EudraCT2020-002495-12; EUCT2024-513625-23-00
Breast cancer
1 Trials
Clinical trial identifier
TWCT00003745; NCT03595059; jRCT2080225314; JapicCTI-205410; EudraCT2020-002495-12; EUCT2024-513625-23-00
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT03595059
PHASE1
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
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
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.

   Click to Show/Hide
Administration Dosage
Participants will be administered ABBV-155 (various doses).
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.
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).
References
Ref 1 A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors