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Therapy Name IDRX-42
Synonyms
Therapy Description

IDRX-42 is a specific KIT inhibitor, which potentially decreases mitosis and tumor cell growth (Cancer Res 2022;82(12_Suppl):Abstract nr 2666).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
IDRX-42 M-4205|M 4205|M4205|IDRX 42|IDRX42 KIT Inhibitor 57 IDRX-42 is a specific KIT inhibitor, which potentially decreases mitosis and tumor cell growth (Cancer Res 2022;82(12_Suppl):Abstract nr 2666).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KIT exon11 gastrointestinal stromal tumor predicted - sensitive IDRX-42 Phase I Actionable In a Phase I trial, IDRX-42 treatment demonstrated safety and resulted in 9 partial responses among 39 evaluable patients with gastrointestinal stromal tumor harboring a KIT exon 11 (n=27), exon 9 (n=13), or exon 8 (n=2) mutation with a clinical benefit rate of 71% overall and 100% as second-line treatment (J Clin Oncol 42, 2024 (suppl 16; abstr 11501); NCT05489237). detail...
KIT K642E gastrointestinal stromal tumor predicted - sensitive IDRX-42 Preclinical - Pdx Actionable In a preclinical study, IDRX-42 treatment inhibited mitosis and decreased tumor growth in a cell line xenograft model and a patient-derived xenograft (PDX) model of gastrointestinal stromal tumor harboring KIT K642E (Cancer Res 2022;82(12_Suppl):Abstract nr 2666). detail...
KIT A502_Y503dup gastrointestinal stromal tumor predicted - sensitive IDRX-42 Preclinical - Pdx Actionable In a preclinical study, IDRX-42 treatment inhibited mitosis and decreased tumor growth in a patient-derived xenograft (PDX) model of gastrointestinal stromal tumor harboring KIT A502_Y503dup (Cancer Res 2022;82(12_Suppl):Abstract nr 2666). detail...
KIT W557Lfs*5 KIT P577del KIT D820G gastrointestinal stromal tumor predicted - sensitive IDRX-42 Preclinical - Pdx Actionable In a preclinical study, IDRX-42 treatment inhibited mitosis and decreased tumor growth in a patient-derived xenograft (PDX) model of gastrointestinal stromal tumor harboring KIT P577del, W557Lfs*5, and D820G (Cancer Res 2022;82(12_Suppl):Abstract nr 2666). detail...
KIT exon9 gastrointestinal stromal tumor predicted - sensitive IDRX-42 Phase I Actionable In a Phase I trial, IDRX-42 treatment demonstrated safety and resulted in 9 partial responses among 39 evaluable patients with gastrointestinal stromal tumors harboring a KIT exon 11 (n=27), exon 9 (n=13), or exon 8 (n=2) mutation with a clinical benefit rate of 71% overall and 100% as second-line treatment (J Clin Oncol 42, 2024 (suppl 16; abstr 11501); NCT05489237). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05489237 Phase I IDRX-42 A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1] Recruiting USA | ESP | DEU | BEL 0


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