First-in-Human Study of IDRX-42 in subjects with Gastrointestinal Stromal Tumors
Research type
Research Study
Full title
A first-in-human (FIH) study of IDRX-42 in participants with metastatic and/or unresectable gastrointestinal stromal tumors (GIST)
IRAS ID
1006526
Contact name
Shrenik Desai
Contact email
Sponsor organisation
IDRx, Inc
Eudract number
2022-001192-14
Clinicaltrials.gov Identifier
Research summary
This study will look at doses of an investigational drug called IDRX-42 in patients with GIST (Gastrointestinal Stromal Tumours) that has spread to other parts of the body and/or cannot be removed by surgery and who have undergone previous therapies which were unsuccessful. This is a first in human study consisting of 2 phases:
Phase 1 (dose escalation) and Phase 1b (indication-specific cohorts). The first part of this study (Phase 1) is completed. The goal was to determine the most appropriate dose for future studies.
The Phase 1b study will assess the safety of IDRX-42 in participants with advanced GIST that has progressed, meaning the tumours have gotten bigger or spread, while taking previous therapy against GIST (e.g., imatinib, sunitinib, regorafenib, and/or ripretinib). This trial will also evaluate the possible anti-tumour effects of IDRX-42 on GIST tumours. The other aims of the study are to learn about any side effects that might occur following IDRX-42 treatment and how much IDRX-42 is in the blood at specific times after taking it, as well as the level of study drug in the body.
GIST is frequently caused by mutations in a normal cell protein called KIT. These mutations lead to excessive activation of the KIT enzyme function, causing the cancer cells to grow and accumulate. IDRX-42 was designed as a highly selective and powerful inhibitor of the enzyme function of the KIT protein. Previous laboratory tests have shown that IDX-42 resulted in significant inhibition of mutated variants of the KIT enzyme with anticancer activity.
Approximately 87 participants, who are 18 years of age or older, will participate in the Phase 1b part of this study.
In addition to the Screening visit, participants will come to the clinic for a total of 5 visits in Cycle 1, 2 visits in Cycle 2 and 1 visit per month for subsequent cycles. Participants will also be contacted every 3 months for up to 1 year after stopping study drug via telephone to check how they are doing.REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0784
Date of REC Opinion
19 Dec 2022
REC opinion
Further Information Favourable Opinion