타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 3개 · 임상 갱신 필요 3개
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab) Astellas·CLDN18.2 (claudin-18.2) 26 trials | zanidatamab (Ziihera, ZW25, zanidatamab-hrii) Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic) 35 trials | |
|---|---|---|---|
Overview Program | Vyloy (zolbetuximab) | Ziihera (zanidatamab) | Enhertu (fam-trastuzumab deruxtecan-nxki) |
Overview Company | Astellas | Jazz Pharmaceuticals / Zymeworks | Daiichi Sankyo / AstraZeneca |
Overview Modality | ANTIBODY | ANTIBODY | ADC |
Overview Target | CLDN18.2 (claudin-18.2) | HER2 (biparatopic) | HER2 |
Overview Indication | CLDN18.2-positive HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer | HER2-positive breast cancer (including regimen-specific first-line and early-stage indications); HER2-low/ultralow breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC and HER2-positive solid tumors: consult the current US label |
Overview Phase | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | Exploits a tight-junction protein that only becomes accessible after malignant transformation, creating tumor selectivity without a novel modality. | 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). | High DAR (~8), bystander effect, HER2-low activity |
Positioning Known limitation | CLDN18.2 heterogeneity and loss under treatment pressure. | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. | HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation. |
Positioning Development positioning | 1L with fluoropyrimidine and platinum chemotherapy | 1L GEA with fluoropyrimidine-platinum ± Tevimbra; 2L+ BTC monotherapy | Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer |
Technology Payload | — | — | DXd (topo-I inhibitor) |
Technology Linker | — | — | Cleavable tetrapeptide |
MoA Mechanism | Binds CLDN18.2 on gastric tumor cells and kills them through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. | Fam-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. |
MoA Biomarker | CLDN18.2 IHC with ≥75% of tumor cells at moderate-to-strong membranous staining. | 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+. | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). |
Toxicology Species | — | — | Cynomolgus monkey, NHP, Rat, Hamster |
Toxicology Animal (cat.) | — | — | NHP |
Toxicology Major finding | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | ILD-like lung findings at high exposure |
Toxicology CRS | N/A | N/A | Minimal |
Toxicology NOAEL | — | — | 10 mg/kg |
Clinical Safety signal | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | ILD-like lung findings at high exposure |
Clinical Selected reported efficacy | — | — | ORR 87% |
Clinical Reported ORR | — | — | 87% vs 81% (THP) |
Clinical Reported PFS | — | — | 40.7 months vs 26.9 months (THP) |
Clinical Reported OS | — | — | Immature at the reported PFS analysis |
Clinical Result source | — | — | FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715) |
Clinical Program phase | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts |
Clinical Trial ref | — | — | NCT04784715 |
Preclinical Animal (cat.) | — | — | Human, Mouse, In vitro |
타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 3개 · 임상 갱신 필요 3개
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab) Astellas·CLDN18.2 (claudin-18.2) 26 trials | zanidatamab (Ziihera, ZW25, zanidatamab-hrii) Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic) 35 trials | |
|---|---|---|---|
Overview Program | Vyloy (zolbetuximab) | Ziihera (zanidatamab) | Enhertu (fam-trastuzumab deruxtecan-nxki) |
Overview Company | Astellas | Jazz Pharmaceuticals / Zymeworks | Daiichi Sankyo / AstraZeneca |
Overview Modality | ANTIBODY | ANTIBODY | ADC |
Overview Target | CLDN18.2 (claudin-18.2) | HER2 (biparatopic) | HER2 |
Overview Indication | CLDN18.2-positive HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer | HER2-positive breast cancer (including regimen-specific first-line and early-stage indications); HER2-low/ultralow breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC and HER2-positive solid tumors: consult the current US label |
Overview Phase | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | Exploits a tight-junction protein that only becomes accessible after malignant transformation, creating tumor selectivity without a novel modality. | 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). | High DAR (~8), bystander effect, HER2-low activity |
Positioning Known limitation | CLDN18.2 heterogeneity and loss under treatment pressure. | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. | HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation. |
Positioning Development positioning | 1L with fluoropyrimidine and platinum chemotherapy | 1L GEA with fluoropyrimidine-platinum ± Tevimbra; 2L+ BTC monotherapy | Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer |
Technology Payload | — | — | DXd (topo-I inhibitor) |
Technology Linker | — | — | Cleavable tetrapeptide |
MoA Mechanism | Binds CLDN18.2 on gastric tumor cells and kills them through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. | Fam-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. |
MoA Biomarker | CLDN18.2 IHC with ≥75% of tumor cells at moderate-to-strong membranous staining. | 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+. | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). |
Toxicology Species | — | — | Cynomolgus monkey, NHP, Rat, Hamster |
Toxicology Animal (cat.) | — | — | NHP |
Toxicology Major finding | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | ILD-like lung findings at high exposure |
Toxicology CRS | N/A | N/A | Minimal |
Toxicology NOAEL | — | — | 10 mg/kg |
Clinical Safety signal | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | ILD-like lung findings at high exposure |
Clinical Selected reported efficacy | — | — | ORR 87% |
Clinical Reported ORR | — | — | 87% vs 81% (THP) |
Clinical Reported PFS | — | — | 40.7 months vs 26.9 months (THP) |
Clinical Reported OS | — | — | Immature at the reported PFS analysis |
Clinical Result source | — | — | FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715) |
Clinical Program phase | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts |
Clinical Trial ref | — | — | NCT04784715 |
Preclinical Animal (cat.) | — | — | Human, Mouse, In vitro |
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