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API CSV32행 · 2개 프로그램

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항목
ADCCurated CoreFDAApproved
telisotuzumab vedotin (Emrelis, ABBV-399, Teliso-V, telisotuzumab-vedotin-tllv)
AbbVie·c-Met
12 trials·t½ ADC in the range of days; free MMAE shorter
ADCStandard DatabasestalePhase 2
Telisotuzumab Adizutecan (Telisotuzumab Adizutecan)
AbbVie·Non Small Cell Lung Carcinoma
13 trials
Overview
Program
Emrelis (telisotuzumab vedotin)Telisotuzumab Adizutecan
Overview
Company
AbbVieAbbVie
Overview
Modality
ADCADC
Overview
Target
c-MetNon Small Cell Lung Carcinoma
Overview
Indication
Previously treated locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpressionMetastatic Colorectal Cancer
Overview
Phase
APPROVEDPHASE_2
Overview
Status
APPROVEDRECRUITING
Overview
Content status
Curated CoreStandard Database
Overview
Data Confidence
Data Confidence · HighData Confidence · Medium
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedInvestigational
Positioning
Key differentiator
Selects high c-Met protein overexpression by IHC, not MET gene mutation. That split is the first row versus MET TKIs.
Positioning
Known limitation
c-Met down-regulation, MMAE efflux, and histologic transformation.
Positioning
Development positioning
Only approved c-Met ADC; confirmatory TeliMET NSCLC-01 versus docetaxel is ongoing.
Technology
Payload
MMAE (microtubule inhibitor)
Technology
Linker
Cleavable vc linker, vedotin chemistry
MoA
Mechanism
Anti-c-Met antibody binds and internalizes; the protease-cleavable linker releases MMAE, which disrupts microtubules and kills the cell plus neighbors via bystander diffusion.
MoA
Biomarker
VENTANA MET (SP44) companion diagnostic. High overexpression is ≥50% of cells with 3+ staining, not MET exon 14 skipping.biomarker analyses showed ORR enrichment in patients with higher c-Met protein expression and MET focal ampli
PK/PD
Half-life
ADC in the range of days; free MMAE shorter
PK/PD
Species
Human
PK/PD
Animal (cat.)
HumanHuman
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Human
Toxicology
Animal (cat.)
Human
Toxicology
Major finding
Peripheral neuropathy, fatigue, decreased appetite, and peripheral edema are common. Grade 3–4 lab signals include lymphopenia and transaminase rises.Phase I Study of Telisotuzumab Adizutecan (Temab-A, ABBV-400), a Novel c-Met Antibody-Drug Conjugate, in Patients With Late-Line Colorectal Cancer and Advanced Solid Tumors.. The antibody-drug conjugate Temab-A comprises the c-Met-targeting antibody telisotuzumab conjugated to a novel topoisomerase 1 inhibitor payload, adizutecan. A first-in-human phase I study (ClinicalTrials.gov identifier: NCT0…
Toxicology
CRS
N/A
Clinical
Safety signal
Peripheral neuropathy, fatigue, decreased appetite, and peripheral edema are common. Grade 3–4 lab signals include lymphopenia and transaminase rises.Phase I Study of Telisotuzumab Adizutecan (Temab-A, ABBV-400), a Novel c-Met Antibody-Drug Conjugate, in Patients With Late-Line Colorectal Cancer and Advanced Solid Tumors.. The antibody-drug conjugate Temab-A comprises the c-Met-targeting antibody telisotuzumab conjugated to a novel topoisomerase 1 inhibitor payload, adizutecan. A first-in-human phase I study (ClinicalTrials.gov identifier: NCT0…
Clinical
Selected reported efficacy
ORR 35%
Clinical
Reported ORR
35%
Clinical
Result source
LUMINOSITY (NCT03539536)
Clinical
Program phase
APPROVEDPHASE_2
Clinical
Trial ref
NCT03539536