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API CSV38행 · 4개 프로그램

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항목
ADCCurated CoreFDAstaleApproved
Tisotumab Vedotin (Tisotumab Vedotin)
Genmab / Pfizer·Solid Malignancies
14 trials
AntibodyCurated CorePhase 3
Erbitux (Erbitux)
Eli Lilly / Merck KGaA·Colorectal Cancer
942 trials·t½ 5.2 h
ADCCurated CoreFDAApproved
trastuzumab deruxtecan (Enhertu, T-DXd, DS-8201)
Daiichi Sankyo / AstraZeneca·HER2
240 trials·t½ ADC ~5.8 days; total antibody ~6.1 days; released DXd ~2.7 days (5.4 mg/kg q3w)
AntibodyCurated CorestalePhase 3
Toripalimab (Toripalimab)
Junshi Biosciences·Gastric Cancer
145 trials
Overview
Program
Tisotumab VedotinErbituxEnhertu (trastuzumab deruxtecan)Toripalimab
Overview
Company
Genmab / PfizerEli Lilly / Merck KGaADaiichi Sankyo / AstraZenecaJunshi Biosciences
Overview
Modality
ADCANTIBODYADCANTIBODY
Overview
Target
Solid MalignanciesColorectal CancerHER2Gastric Cancer
Overview
Indication
Colorectal Neoplasms; Carcinoma, Non-Small-Cell LungHead and Neck Cancer Squamous CellHER2+ breast cancer, HER2-low, gastricMetastatic Colorectal Cancer; Liver Metastases
Overview
Phase
APPROVEDPHASE_3APPROVEDPHASE_3
Overview
Status
APPROVEDRECRUITINGAPPROVEDRECRUITING
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · HighData Confidence · HighData Confidence · High
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EmergingDevelopment Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedInvestigationalFDA approvedInvestigational
Positioning
Key differentiator
novel strategies of biotherapeuticsHigh DAR (~8), bystander effect, HER2-low activitynovel safety signals were identified
Positioning
Known limitation
resistance to anti-EGFR therapy by transcriptional reprogramming in patient-derived colorectal cancer modelsHER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation.downregulation of p-Akt and Ki-67
Positioning
Development positioning
Leading efficacy in HER2 ADC class
Technology
Payload
DXd (topo-I inhibitor)
Technology
Linker
Cleavable tetrapeptide
MoA
Mechanism
targeting the epidermal growth factor receptorFam-trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate: humanized anti-HER2 IgG1 linked via a cleavable tetrapeptide linker to DXd, a membrane-permeable topoisomerase I inhibitor. After binding HER2 on tumor cells, the conjugate is internalized; lysosomal proteases cleave the linker and release DXd, causing DNA damage and apoptosis. Released DXd can exert a bystander effect in neighboring cells.Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production
MoA
Biomarker
EGFR SR could be established with highHER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2).PD-L1)-positive
PK/PD
Half-life
5.2 hADC ~5.8 days; total antibody ~6.1 days; released DXd ~2.7 days (5.4 mg/kg q3w)
PK/PD
Species
PigMinipig, Pig, Human, Tumor response (ORR, PFS), ILD incidence rises with exposureRat
PK/PD
Animal (cat.)
In vitroHuman, In vitroRat, In vitro
PK/PD
Experiment
PharmacokineticPharmacokineticPD
PK/PD
Biodistribution
Systemic exposure with tumor-selective HER2-mediated uptake
Toxicology
Species
PigCynomolgus monkey, NHP, Rat, Minipig, Pig, Hamster, HumanRat
Toxicology
Animal (cat.)
In vitroNHPRat, In vitro
Toxicology
Major finding
Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occurA Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of A140 Injection and Cetuximab (Erbitux ® ) in Healthy Chinese Male Subjects.. This study aimed to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity of the proposed A140 with those of cetuximab (Erbitux ® ) in healthy Chinese male subjects. We conducted a randomized, single-dose, double-b…ILD-like lung findings at high exposureThrombocytopenia and Splenomegaly in Locally Advanced Rectal Cancer Patients Receiving Total Neo
Toxicology
CRS
Minimal
Toxicology
NOAEL
10 mg/kg
Clinical
Safety signal
Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occurA Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of A140 Injection and Cetuximab (Erbitux ® ) in Healthy Chinese Male Subjects.. This study aimed to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity of the proposed A140 with those of cetuximab (Erbitux ® ) in healthy Chinese male subjects. We conducted a randomized, single-dose, double-b…ILD-like lung findings at high exposureThrombocytopenia and Splenomegaly in Locally Advanced Rectal Cancer Patients Receiving Total Neo
Clinical
Selected reported efficacy
ORR 23.8%ORR 52.2%ORR 79.7%ORR 75.5%
Clinical
Reported ORR
23.8%52.2%79.7%75.5%
Clinical
Reported PFS
NA8.2
Clinical
Reported OS
NA33.7
Clinical
Result source
ClinicalTrials.gov NCT03438396ClinicalTrials.gov NCT00527111ClinicalTrials.gov NCT03529110ClinicalTrials.gov NCT03581786
Clinical
Program phase
APPROVEDPHASE_3APPROVEDPHASE_3
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT03438396NCT00527111NCT03529110NCT03581786
Preclinical
Animal (cat.)
Human, Mouse, In vitro