Study to Evaluate the Effectiveness and Safety of NB003 Compared to Regorafenib in Adults With Advanced Gastrointestinal Stromal Tumors GIST

What this Trial Is About

Researchers are evaluating NB003, a drug being studied for patients aged 18 years and older with advanced gastrointestinal stromal tumors GIST who have experienced disease progression or intolerance after prior treatments with imatinib and sunitinib or imatinib alone. This phase IIIII, multicenter, open-label study aims to assess the efficacy, safety, and pharmacokinetics of NB003. The study includes two parts Part 1 compares NB003 to regorafenib in patients needing third-line therapy, while Part 2 evaluates NB003 alone in patients requiring second-line therapy after imatinib failure. Participants receive NB003 administered orally at 15 mg twice daily on a continuous schedule in 28-day cycles. In Part 1, NB003 is compared to regorafenib given at 160 mg once daily in 28-day cycles. The study uses a crossover design and is randomized, open-label, and conducted at multiple centers. Treatments continue as per protocol with efficacy and safety monitored over time. During the study, participants undergo various assessments including tumor measurements according to mRECIST criteria, molecular pathology testing for KIT gene mutations, and evaluations of physical health and organ function. Researchers monitor progression-free survival and objective response rate over approximately 24 to 28 months, along with additional outcomes such as duration of response and overall survival. Safety is regularly assessed, and participants are followed until study completion around September 2028, with the primary outcome measured from randomization until database cut-off, about 28 months.

Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)