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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 52 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 | ESP 0


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