Full title: 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)
Age: 18+
Phase: 1b
Locations:
London – The Royal Marsden Hospital
Brief summary:
This is the first clinical trial of IDRX-42. The study is designed to evaluate the safety, tolerability, and preliminary antitumor activity of IDRX-42 in adult participants with advanced (metastatic and/or surgically unresectable) GIST.
Eligible participants will have metastatic and/or surgically unresectable GIST. The study consists of 2 parts. Phase 1 comprises dose escalation to assess clinical and pharmacologic profile and safety/tolerability after failure of at least prior imatinib and support choice of the recommended phase 1b dose(s) and schedule(s) doses. Phase 1b expansion will enroll separate cohorts of participants defined by numbers of lines of prior GIST therapy at the selected doses to assess the preliminary antitumor effect of IDRX-42 and further characterize the safety profile of IDRX-42.
More information can be found at clinicaltrials.gov
To find out more about this trial and whether you could take part, talk to your clinical team.
