Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0GGKEV)
ADC Name
NBE-002
Synonyms
NBE-002; BI 3702025
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Organization
NBE-Therapeutics (Top20 MNC) (Originator)
Drug Status
Phase 1/2 (discontinued)
Drug-to-Antibody Ratio
3.7-3.9
Structure
Antibody Name
HuXBR1-402
  Antibody Info 
Antigen Name
Inactive tyrosine-protein kinase transmembrane receptor ROR1 (ROR1)
  Antigen Info 
Payload Name
PNU-159682
  Payload Info 
Payload Target
DNA topoisomerase 2-alpha (TOP2A)
  Target Info 
Linker Name
LPETG-Gly5-EDA
  Linker Info 
Conjugate Type
Enzymatic Catalysis
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
Breast cancer
1 Trials
Clinical trial identifier
NCT04441099
Unspecific solid tumor
1 Trials
Clinical trial identifier
NCT04441099
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  NCT04441099
PHASE1|||PHASE2
A First-in-Human, Phase 1/2 Study of NBE-002, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced 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
Eligibility requires age ≥18, progressive advanced tumors (Phase 1: any solid tumor refractory to standard therapy; Phase 2: TNBC ≤3L or other solid tumors ≤3L), measurable disease (Phase 2 only), ECOG 0-2 (Phase 1) or 0-1 (Phase 2), and adequate organ function. Key exclusions include prior ROR1-targeting therapy, active CNS metastases, unresolved Grade >1 toxicity from prior treatments, recent anticancer therapies/surgeries, significant comorbidities, and secondary malignancies within 3 years.

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Administration Dosage
NBE-002 will be given intravenously on Day 1 of repeated 28-day cycles.
Related Clinical Trial
NCT Number NCT04441099  Clinical Status PHASE1|||PHASE2
Clinical Description A First-in-Human, Phase 1/2 Study of NBE-002, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors
Primary Endpoint
The Phase 1 portion focuses on determining the RP2D through DLT assessments over 48 months, while Phase 2 evaluates anti-tumor activity per RECIST v1.1 for up to 60 months.
Other Endpoint
Safety monitoring (CTCAE v5.0) and preliminary efficacy (RECIST v1.1) run through 48-60 months, with additional PK (NBE-002 concentrations) and immunogenicity (anti-drug antibodies) profiling.
References
Ref 1 NBE-002 in Patients With Advanced Solid Tumors