NCT07379047

A Multicenter, Open-label Clinical Study to Evaluate the Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Ningbo Newbay Technology Development Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

NB003-04 is a phase II/III, multicenter, open-label clinical study designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of NB003 in patients with gastrointestinal stromal tumors aged 18 years and above (or the legal adult age of consent per local regulations, whichever is older). Participants who are eligible for this study are those who have experienced disease progression or documented intolerance following treatment with either imatinib and sunitinib or following treatment with imatinib. This study consists of two parts. Part 1 (hereinafter referred to as Part 1) compares the efficacy of NB003 versus regorafenib in patients who need a third-line therapy for GIST who have failed sequential therapy with imatinib and sunitinib. Part 2 (hereinafter referred to as Part 2) evaluates the efficacy of NB003 in patients who need a second-line therapy for GIST who have failed treatment with imatinib.

Conditions

• GIST - Gastrointestinal Stromal Tumor
• Advanced

Interventions

Type	Name	Description
DRUG	NB003	15 mg BID on a continuous schedule in 28-day cycles.
DRUG	regorafenib	Regorafenib is an approved multi-kinase inhibitor administered orally at a dose of 160 mg once daily (QD).

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-08-01
• Completion: 2028-09-01
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

9 sites across 1 country: China