Theseus Pharmaceuticals to present data from Phase 1/2 THE-630 trial

Theseus Pharmaceuticals announced that initial dose escalation data from the ongoing phase 1/2 study of THE-630 in advanced gastrointestinal stromal tumors were accepted for online publication at the 2023 American Society of Clinical Oncology Annual Meeting, taking place June 2-6, in Chicago, Illinois. The abstract selected for online publication was submitted on February 14, 2023. On May 25, 2023, Theseus plans to host a virtual investor event to present data with an updated cutoff date. The data to be presented from the ongoing dose escalation study are expected to include preliminary safety, pharmacokinetic, and clinical activity data through cohort 6, as well as an analysis of circulating tumor DNA data through cohort 5. THE-630 is a pan-variant tyrosine kinase inhibitor of the receptor tyrosine kinase KIT, designed for patients with GIST that have developed resistance to earlier lines of therapy. The primary objectives of the phase 1 dose escalation portion of the study are to evaluate the safety profile of THE-630, including the determination of a recommended phase 2 dose in GIST patients who have received imatinib and at least one other TKI. Secondary objectives include determining the PK profile of THE-630, and to characterize preliminary evidence of antitumor activity.