Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0GGKEV
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| ADC Name |
NBE-002
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| Synonyms |
NBE-002; BI 3702025
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| Organization |
NBE-Therapeutics (Top20 MNC) (Originator)
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| Drug Status |
Phase 1/2 (discontinued)
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| Drug-to-Antibody Ratio |
3.7-3.9
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| Structure |
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| Antibody Name |
HuXBR1-402
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Antibody Info | ||||
| Antigen Name |
Inactive tyrosine-protein kinase transmembrane receptor ROR1 (ROR1)
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Antigen Info | ||||
| Payload Name |
PNU-159682
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 2-alpha (TOP2A)
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Target Info | ||||
| Linker Name |
LPETG-Gly5-EDA
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Linker Info | ||||
| Conjugate Type |
Enzymatic Catalysis
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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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| Unspecific solid tumor |
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 |
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.
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| 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.
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| 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.
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