Therapy Detail
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| Therapy Name | EP0031 |
| Synonyms | |
| Therapy Description |
EP0031 inhibits RET, potentially leading to decreased growth of tumors expressing RET fusions and mutations, and resulting in antitumor activity (NCI Drug Dictionary, J Clin Oncol 41, 2023 (suppl 16; abstr 3007)). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| EP0031 | EP-0031|EP 0031|A400|A-400|A 400|KL590586 | RET Inhibitor 53 | EP0031 inhibits RET, potentially leading to decreased growth of tumors expressing RET fusions and mutations, and resulting in antitumor activity (NCI Drug Dictionary, J Clin Oncol 41, 2023 (suppl 16; abstr 3007)). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| RET mutant | Advanced Solid Tumor | predicted - sensitive | EP0031 | Phase Ib/II | Actionable | In a Phase I/II trial (KL400-I/II-01), EP0031 treatment was well tolerated and demonstrated preliminary activity in patients with advanced solid tumors harboring mutations in RET, resulting in an objective response rate of 64%, with responses being observed in patients with non-small cell lung cancer, medullary thyroid cancer and pancreatic cancer (J Clin Oncol 41, 2023 (suppl 16; abstr 3007); NCT05265091). | detail... |
| RET mutant | lung non-small cell carcinoma | predicted - sensitive | EP0031 | Phase Ib/II | Actionable | In a Phase I/II trial (KL400-I/II-01), EP0031 treatment was well tolerated in non-small cell lung cancer (NSCLC) patients harboring RET mutations, and resulted in an objective response rate (ORR) of 63% (20/32, 1 complete response (CR)) and disease control rate (DCR) of 91% in pretreated patients, and an ORR of 76% (19/25, 1 CR) and DCR of 92% with median duration of response not reached in treatment-naive patients, and an overall CNS DCR of 100% (J Clin Oncol 41, 2023 (suppl 16; abstr 3007); NCT05265091). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05443126 | Phase Ib/II | EP0031 | A Study of EP0031 in Patients With Advanced RET-altered Malignancies | Recruiting | USA | GBR | FRA | ESP | 1 |
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