Therapy Detail
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| Therapy Name | ALK201 |
| Synonyms | |
| Therapy Description |
ALK201 is an antibody-drug conjugate (ADC) comprising a monoclonal antibody targeting FGFR2b linked to exatecan, which inhibits FGFR2b signaling and potentially induces antibody-dependent cellular cytotoxicity and inhibits tumor growth (Cancer Res (2025) 85 (8_Supplement_2): LB227). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| ALK201 | ALK-201|ALK 201 | FGFR2 Antibody 5 | ALK201 is an antibody-drug conjugate (ADC) comprising a monoclonal antibody targeting FGFR2b linked to exatecan, which inhibits FGFR2b signaling and potentially induces antibody-dependent cellular cytotoxicity and inhibits tumor growth (Cancer Res (2025) 85 (8_Supplement_2): LB227). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR2 positive | stomach cancer | predicted - sensitive | ALK201 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, ALK201 induced antibody-dependent cellular cytotoxicity in gastric cancer cells expressing FGFR2b in culture and inhibited tumor growth in a cell line xenograft and patient-derived xenograft (PDX) model (Cancer Res (2025) 85 (8_Supplement_2): LB227). | detail... |
| FGFR2 positive | lung non-small cell carcinoma | predicted - sensitive | ALK201 | Preclinical - Pdx | Actionable | In a preclinical study, ALK201 inhibited tumor growth in a patient-derived xenograft (PDX) model of FGFR2b-expressing squamous non-small cell lung cancer (Cancer Res (2025) 85 (8_Supplement_2): LB227). | detail... |
| FGFR2 positive | breast cancer | predicted - sensitive | ALK201 | Preclinical - Pdx | Actionable | In a preclinical study, ALK201 inhibited tumor growth in a patient-derived xenograft (PDX) model of FGFR2b-expressing breast cancer (Cancer Res (2025) 85 (8_Supplement_2): LB227). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06656390 | Phase Ib/II | ALK201 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors | Recruiting | AUS | 0 |
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