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타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 다음 갱신 D-5 · 마지막 9월 2일

현재 선택: 5 · 임상 갱신 필요 4

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API CSV33행 · 5개 프로그램

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항목
AntibodyCurated CoreFDAApproved
zanidatamab (Ziihera, ZW25, zanidatamab-hrii)
Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic)
35 trials·t½ ~7 days
AntibodyLimited DatastalePhase 2
TT-00420 (TT-00420)
TransThera Sciences (Nanjing), Inc…·HER2
1 trials·t½ 34 h
AntibodyLimited DatastalePhase 2
KN046 (KN046)
Jiangsu Alphamab Biopharmaceutical…·Colorectal Cancer
29 trials
ADCLimited DatastalePhase 2
KN026 (KN026)
Shanghai JMT-Bio Inc.·Advanced Breast Cancer
17 trials
ADCLimited DatastalePhase 1
GQ1001 (GQ1001)
GeneQuantum Healthcare (Suzhou) Co…·HER2
2 trials
Overview
Program
Ziihera (zanidatamab)TT-00420KN046KN026GQ1001
Overview
Company
Jazz Pharmaceuticals / ZymeworksTransThera Sciences (Nanjing), Inc.Jiangsu Alphamab Biopharmaceuticals Co., LtdShanghai JMT-Bio Inc.GeneQuantum Healthcare (Suzhou) Co., Ltd.
Overview
Modality
ANTIBODYANTIBODYANTIBODYADCADC
Overview
Target
HER2 (biparatopic)HER2Colorectal CancerAdvanced Breast CancerHER2
Overview
Indication
First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancerAdvanced Solid Tumor; CholangiocarcinomaHER2-positive Colorectal Cancer; HER2-positive Biliary Tract CancerHER2-positive Colorectal Cancer; HER2-positive Biliary Tract CancerHER2-positive Breast Cancer; HER2-positive Biliary Tract Cancer
Overview
Phase
APPROVEDPHASE_2PHASE_2PHASE_2PHASE_1
Overview
Status
APPROVEDACTIVERECRUITINGRECRUITINGACTIVE
Overview
Content status
Curated CoreLimited DataLimited DataLimited DataLimited Data
Overview
Data Confidence
Data Confidence · HighData Confidence · LowData Confidence · LowData Confidence · LowData Confidence · Low
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EmergingDevelopment Signal · EmergingDevelopment Signal · EmergingDevelopment Signal · Watch
Overview
Approval status
FDA approvedInvestigationalInvestigationalInvestigationalInvestigational
Positioning
Key differentiator
Dual-epitope binding drives receptor clustering, faster internalization, and stronger signaling blockade than either monoclonal alone. In GEA the label splits IHC 3+ (chemo doublet) from IHC 3+ or 2+/ISH+ (chemo + Tevimbra).
Positioning
Known limitation
HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling.
Positioning
Development positioning
Challenges the ToGA trastuzumab-chemo backbone in 1L HER2+ GEA; still the only HER2 agent with a dedicated BTC indication.
MoA
Mechanism
Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity.
MoA
Biomarker
GEA: PATHWAY 4B5 IHC and VENTANA Dual ISH. IHC 3+ for chemo doublet; IHC 3+ or IHC 2+/ISH+ when Tevimbra is added. BTC: HER2 IHC 3+.
PK/PD
Half-life
~7 days34 h
PK/PD
Species
Cynomolgus monkey, Human, OS and PFS in GEA, ORR and DOR in BTC
PK/PD
Animal (cat.)
Human, NHP, In vitro
PK/PD
Experiment
pd
Toxicology
Species
Human
Toxicology
Major finding
Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class.First-In-Human Phase I Study of Tinengotinib (TT-00420), a Multiple Kinase Inhibitor, as a Single Agent in Patients With Advanced Solid Tumors.. This first-in-human phase I dose-escalation study evaluated the safety, pharmacokinetics, and efficacy of tinengotinib (TT-00420), a multi-kinase inhibitor targeting fibroblast growth factor receptors 1-3 (FGFRs 1-3), Janus kinase 1/2, vascular endothelia…pneumonitis), all ADC trialsSafety and Efficacy of KN046 in Combination with KN026 in Patients with Advanced HER2-Positive Breast Cancer: A Phase II Trial.. In this study, we report the results from a phase II trial assessing the safety and efficacy of KN046 in combination with KN026 in patients with HER2-positive metastatic breast cancer, who had progressed after prior anti-HER2 combination therapies. Female patients with m…Site-specific ligase-dependent conjugation with ring-opening linker improves safety and stability of HER2-targeting ADCs.. Most of current ADCs have the problems of heterogeneity and payload-mediated off-target toxicities due to random conjugation and unstable linker. Herein we apply site-specific ligase-dependent conjugation (LDC) for GQ1001 and GQ1005, where humanized anti-HER2 antibody is linke…
Toxicology
CRS
N/A
Clinical
Safety signal
Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class.First-In-Human Phase I Study of Tinengotinib (TT-00420), a Multiple Kinase Inhibitor, as a Single Agent in Patients With Advanced Solid Tumors.. This first-in-human phase I dose-escalation study evaluated the safety, pharmacokinetics, and efficacy of tinengotinib (TT-00420), a multi-kinase inhibitor targeting fibroblast growth factor receptors 1-3 (FGFRs 1-3), Janus kinase 1/2, vascular endothelia…pneumonitis), all ADC trialsSafety and Efficacy of KN046 in Combination with KN026 in Patients with Advanced HER2-Positive Breast Cancer: A Phase II Trial.. In this study, we report the results from a phase II trial assessing the safety and efficacy of KN046 in combination with KN026 in patients with HER2-positive metastatic breast cancer, who had progressed after prior anti-HER2 combination therapies. Female patients with m…Site-specific ligase-dependent conjugation with ring-opening linker improves safety and stability of HER2-targeting ADCs.. Most of current ADCs have the problems of heterogeneity and payload-mediated off-target toxicities due to random conjugation and unstable linker. Herein we apply site-specific ligase-dependent conjugation (LDC) for GQ1001 and GQ1005, where humanized anti-HER2 antibody is linke…
Clinical
Selected reported efficacy
ORR 52%ORR 4%
Clinical
Reported ORR
52%4%
Clinical
Reported PFS
~5.5 mo
Clinical
Reported OS
15.54
Clinical
Result source
HERIZON-BTC-01 (NCT04466891)ClinicalTrials.gov NCT04925947
Clinical
Program phase
APPROVEDPHASE_2PHASE_2PHASE_2PHASE_1
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT04466891NCT04925947
Preclinical
Animal (cat.)
Unknown