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항목
ADCCurated CorestaleApproved
disitamab vedotin (Disitamab Vedotin, RC48)
RemeGen·HER2
159 trials
ADCStandard DatabasestalePhase 2
disitamab vedotin (Disitamab Vedotin, RC48, Disitamab Vedotin Tislelizumab)
RemeGen·HER2
17 trials
AntibodyLimited DatastalePhase 2
BT8009 (BT8009)
BicycleTx Limited·HER2
1 trials
Overview
Program
Disitamab Vedotin (RC48)Disitamab Vedotin TislelizumabDisitamab Vedotin and ToripalimabBT8009
Overview
Company
RemeGenRemeGenRemeGenBicycleTx Limited
Overview
Modality
ADCADCADCANTIBODY
Overview
Target
HER2HER2HER2HER2
Overview
Indication
HER2+ urothelial, gastric, breastHer2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial CarcinomaMuscle Invasive Bladder Cancer; HER2 ExpressionUrinary Bladder Neoplasm; Triple Negative Breast Neoplasms
Overview
Phase
APPROVEDPHASE_2PHASE_2PHASE_2
Overview
Status
ACTIVEACTIVEACTIVERECRUITING
Overview
Content status
Curated CoreStandard DatabaseLimited DataLimited Data
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · structured catalogEditorial scope · limited dataEditorial scope · limited data
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EmergingDevelopment Signal · EmergingDevelopment Signal · Emerging
Overview
Approval status
Approved (flag incomplete)InvestigationalInvestigationalInvestigational
Positioning
Key differentiator
Novel anti-HER2 mAb with distinct epitope———
Positioning
Known limitation
resistance mechanisms, optimize payload delivery, and minimize off-target toxicity———
Positioning
Development positioning
2L+———
Technology
Payload
MMAE———
Technology
Linker
Cleavable———
MoA
Mechanism
Disitamab vedotin binds a distinct HER2 epitope (different from trastuzumab), internalizes, and releases MMAE via cleavable linker, causing microtubule disruption and apoptosis.———
MoA
Biomarker
HER2 expression (IHC); activity in HER2+ urothelial and gastric cancers.———
Toxicology
Species
Cynomolgus monkey———
Toxicology
Animal (cat.)
NHP———
Toxicology
Major finding
Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets.———
Toxicology
CRS
N/A———
Clinical
Safety signal
Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets.———
Clinical
Program phase
APPROVEDPHASE_2PHASE_2PHASE_2
Clinical
Trial activity
No active/completed counts———