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- IDRX-42 / IDRx
StrateGIST 1: A first-in-human (FIH), phase 1 study of IDRX-42 in patients with metastatic gastrointestinal stromal tumors resistant to prior treatment with tyrosine kinase inhibitors (TKIs). (S100bc) - Apr 24, 2024 - Abstract #ASCO2024ASCO_799;
P1
IDRX-42 demonstrates promising clinical activity and a favorable safety profile in patients with advanced GIST following resistance to prior TKIs. Dose finding continues, and additional cohorts are ongoing.
- || IDRX-42 / IDRx
Enrollment change, Stroma, Metastases: A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1] (clinicaltrials.gov) - Apr 9, 2024
P1, N=240, Recruiting, Sponsor: IDRx, Inc.
Dose finding continues, and additional cohorts are ongoing. N=143 --> 240
- | Journal, Stroma: KIT/PDGFRA inhibitors for the treatment of gastrointestinal stromal tumors: getting to the gist of the problem. (Pubmed Central) - Mar 11, 2024
Despite the outstanding results of first-line imatinib in advanced GIST, resistance ultimately occurs mainly through secondary mutations in KIT/PDGFRA...However, it is now recognized that the situation is more intricate, with various factors interacting with KIT and PDGFRA, playing a crucial role in the response and resistance to treatments. Future strategies in the management of advanced GIST should integrate driver inhibition with the blockade of other molecules to enhance cell death and establish enduring responses in patients.
- | IDRX-42 / IDRx, M4205 / EMD Serono
Preclinical, Journal, Stroma: Anti-tumor efficacy of the novel KIT inhibitor IDRX-42 (formerly M4205) in patient- and cell line-derived xenograft models of gastrointestinal stromal tumor (GIST). (Pubmed Central) - May 24, 2023
The novel kinase inhibitor induced volumetric responses, decreased mitotic activity and had antiproliferative effects. In models with KIT exon 13 mutation IDRX-42 induced characteristic myxoid degeneration.
- | M4205 / EMD Serono
Journal, Stroma, Metastases: Identification of M4205?A Highly Selective Inhibitor of KIT Mutations for Treatment of Unresectable Metastatic or Recurrent Gastrointestinal Stromal Tumors. (Pubmed Central) - Feb 27, 2023
An imidazopyridine hit featuring excellent kinase selectivity was identified in a high-throughput screen (HTS) and optimized to the clinical candidate M4205 (IDRX-42). This molecule has a superior profile compared to approved drugs, suggesting a best-in-class potential for recurrent and metastatic GISTs driven by KIT mutations.
- ||||| IDRX-42 / IDRx
Clinical: High throughput drug screen leading to identification of a new KIT inhibitor (M4205, IDRX-42) with high selectivity and broad coverage of clinically relevant KIT mutants. Read Blum et al J Med Chem 2023 and see https://t.co/oL2D510BmW NCT05489237 (Twitter) - Feb 7, 2023
P1
- IDRX-42 / IDRx
Phase 1/1b first-in-human study of IDRX-42, a novel oral tyrosine kinase inhibitor (TKI), in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GISTs). (Available On Demand; Poster Board No. N18) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_362;
P1
Enrollment is ongoing (NCT05489237). Clinical trial information: NCT05489237.
- ||||| imatinib / Generic mfg., IDRX-42 / IDRx
FDA event, P1 data, Orphan drug: Novel Kit inhibitor IDRX-42 showing efficacy in imatinib resistant #GIST xenograft models- @schoffski. ⭐️ Phase I study underway ✅ FDA orphan drug designation #CTOS2022 #CTOSTweeTOS #sarcoma @ctosociety @OncoAlert @seppobauer @AgaWozniak1 (Twitter) - Nov 19, 2022
- |||| IDRX-42 / IDRx
Our PDX work on IDRX-42 in GIST was presented today #CTOS2022 by @schoffski Yet another successful story currently being translated our #XenoSarc findings into clinic. #CTOSTweeTOS (Twitter) - Nov 19, 2022
- |||| IDRX-42 / IDRx
Exciting activity of IDRX-42 a novel KIT inhibitor in #GIST PDX models @schoffski #CTOS2022 #CTOSTweeTOS @ctosociety (Twitter) - Nov 19, 2022
- |||| imatinib / Generic mfg., IDRX-42 / IDRx
IDRX42 is effective against imatinib resistant #GIST in multiple models by @schoffski #CTOS2022 #ctostweetos @OncoAlert ?v654a (Twitter) - Nov 18, 2022
- IDRX-42 / IDRx
FIRST-IN-HUMAN PHASE 1/1B STUDY OF IDRX-42, A NOVEL ORAL TYROSINE KINASE KIT INHIBITOR, IN PARTICIPANTS WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMORS () - Sep 9, 2022 - Abstract #CTOS2022CTOS_312;
Objective: The majority of gastrointestinal stromal tumors (GISTs) are driven by constitutively activated kinases, either KIT or PDGFRA, and respond to treatment with tyrosine kinase inhibitors (TKI) such as imatinib, sunitinib, regorafenib, and ripretinib. Not applicable
- IDRX-42 / IDRx
ANTI-TUMOR EFFECTS OF THE NOVEL KIT MUTANT INHIBITOR M4205/IDRX-42 IN GASTROINTESTINAL STROMAL TUMOR (GIST) XENOGRAFT MODELS (VCC, East Exhibition Hall A) - Sep 9, 2022 - Abstract #CTOS2022CTOS_98;
- ||| IDRX-42 / IDRx
Enrollment open, Stroma, Metastases: A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1] (clinicaltrials.gov) - Aug 17, 2022
P1, N=143, Recruiting, Sponsor: IDRx, Inc.
Not applicable Not yet recruiting --> Recruiting
- |||||| IDRX-42 / IDRx
Clinical, P1 data: Yet another compound tested in our lab entering Phase 1 testing in GIST patients now, based on results obtainted in our xenografts. See recent press releases from IDRx, Inc. on their plans with the novel KIT inhibitor IDRX-42 and see our poster De Sutter et al. at ESMO in Paris (Twitter) - Aug 9, 2022
- | IDRX-42 / IDRx
New P1 trial, Stroma, Metastases: A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1] (clinicaltrials.gov) - Aug 5, 2022
P1, N=143, Not yet recruiting, Sponsor: IDRx, Inc.