Therapy Detail
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| Therapy Name | Ficonalkib |
| Synonyms | |
| Therapy Description |
Ficonalkib (SY-3505) is a third-generation ALK inhibitor with activity against wild-type and mutant ALK, which potentially inhibits tumor growth (PMID: 38295954). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ficonalkib | SY-3505|SY3505|SY 3505|CT-3505|CT3505|CT 3505 | ALK Inhibitor 32 | Ficonalkib (SY-3505) is a third-generation ALK inhibitor with activity against wild-type and mutant ALK, which potentially inhibits tumor growth (PMID: 38295954). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ALK rearrange ALK G1202R | lung non-small cell carcinoma | predicted - sensitive | Ficonalkib | Case Reports/Case Series | Actionable | In a Phase I/II trial, Ficonalkib (SY-3505) treatment was well tolerated and resulted in an objective response rate (ORR) of 47.5% (38/80, all partial responses (PR)), a disease control rate of 92.5%, median duration of response of 9.23 months, and median progression-free survival of 7.95 in Chinese patients with ALK-positive non-small cell lung cancer, with an ORR of 70% (7/10) in patients with ALK G1202R (PMID: 38295954; NCT05257512). | 38295954 |
| ALK rearrange | lung non-small cell carcinoma | sensitive | Ficonalkib | Phase Ib/II | Actionable | In a Phase I/II trial, Ficonalkib (SY-3505) treatment was well tolerated and resulted in an objective response rate (ORR) of 47.5% (38/80, all partial responses (PR)), disease control rate of 92.5%, median duration of response of 9.23 months, and median progression-free survival of 7.95 months, and an intracranial ORR of 37.5% (12/32, 4 complete responses, 8 PR) and intracranial DCR of 100% (32/32) in Chinese patients with ALK-positive non-small cell lung cancer (PMID: 38295954; NCT05257512). | 38295954 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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