Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0XKMVA
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| ADC Name |
SYS6002
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| Synonyms |
SYS6002; CRB-701
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| Organization |
CSPC Innovation Pharmaceutical (Originator);Corbus Pharmaceuticals
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
2
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| Structure |
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| Antibody Name |
Anti-Nectin-4 antibody
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Antibody Info | ||||
| Antigen Name |
Nectin-4 (NECTIN4)
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Antigen Info | ||||
| Payload Name |
MMAE
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
NH2-PEG3-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Enzymatic Catalysis
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| Combination Type |
envedotin
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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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| Cervical cancer |
1 Trials
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| Head and neck cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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1 Trials
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| Urothelial cancer |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Elimination Half-Life (t1/2) | 4-5 | day |
The half-lives of TAb, ADC and MMAE were 4-6 days, 4-5 days and 5-10 days, respectively.
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[1] |
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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 | [2] | ||||
| Patients Enrolled |
Key eligibility: Inclusion requires nectin-4+ advanced/metastatic solid tumors with ≥1 prior therapy failure; Exclusion criteria cover active CNS metastases, grade≥2 neuropathy, uncontrolled diabetes (HbA1c≥8%), ocular/liver/pulmonary diseases, and significant comorbidities.
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| Administration Dosage |
CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1
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| Related Clinical Trial | |||||
| NCT Number | NCT06265727 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients with Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include MTD/PADR determination via DLT assessment in Part A (21-day window) and efficacy evaluation through DCR (CR+PR+SD≥4 months) and ORR (CR+PR per RECIST 1.1) in Parts B&C (6-month follow-up).
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| Other Endpoint |
Secondary objectives cover safety profiling (TEAEs by CTCAE v5.0) across all phases and PK analysis (9-week duration) of CRB-701 components including total ADC/free MMAE/total antibody parameters (Cmax/Tmax/AUC) for single/multiple dosing.
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References