TRIAL DETAIL

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

Drug:
Trial Name:
A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Not yet recruiting
Phase:
3
Start Date 12/05/2025
Age of Trial (yrs) 0
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT/PDGFRA
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
300383 2025-522229-37-00 ( EU Trial (CTIS) Number )
Sponsor:
GlaxoSmithKline
Patient Contact:
US GSK Clinical Trials CallCenter 877-379-3718 GSKClinicalSupportHD@gsk.com EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Eligibility Criteria:

Inclusion Criteria:

Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.

Trial Links

Trial Results

Drug Information

The Potential of c-KIT Kinase inhibitors in Cancer Treatment
 
MedCity News 8/2/2022: Aiming to bring drug combos into earlier lines of cancer therapy, IDRx lands $122M
 
IDRx Presents Preliminary Clinical Data from Ongoing Phase 1 StrateGIST Study at CTOS 2023 Supporting Best-in-Class Potential of IDRX-42 in Patients with GIST
 
Merck 2/28/2025 M4205 (IDRX-42) is a highly selective and potent inhibitor of relevant oncogenic driver and resistance variants of KIT in cancer
 

Trial Sites

Name
Address
City
State
Zip
Country
1505 Holcombe Blvd.
Houston
TX
77030
USA
Tacoma
WA
98405
USA
Omaha
NE
68130
USA