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Study identifier: NCT07379047 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: GIST - Gastrointestinal Stromal Tumor · Advanced  ·  Sponsor: Ningbo Newbay Technology Development Co., Ltd

PhasePhase 2/Phase 3
Planned participants255
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Zhi Zhang  ·  +86-21-68880576  ·  zzhang@newbaypharma.com

Always discuss trial participation with your own doctor first.

Locations (32)

The First Affiliated Hospital of Anhui Medical UniversityHefei, Anhui, ChinaNot Yet Recruiting
The Second Hospital of Anhui Medical UniversityHefei, Anhui, ChinaRecruiting
Beijing Cancer HospitalBeijing, Beijing Municipality, ChinaRecruiting
The First Affiliated Hospital of Chongqing Medical UniversityChongqing, Chongqing Municipality, ChinaNot Yet Recruiting
The First Affiliated Hospital of Fujian Medical UniversityFuzhou, Fujian, ChinaNot Yet Recruiting
The First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, Guandong, ChinaNot Yet Recruiting
Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, ChinaNot Yet Recruiting
Guangxi Medical University Affiliated Cancer HospitalNanning, Guangxi, ChinaNot Yet Recruiting
The Affiliated Hospital of Guizhou Medical UniversityGuiyang, Guizhou, ChinaNot Yet Recruiting
The Fourth Hospital of Hebei Medical UniversityShijiazhuang, Hebei, ChinaNot Yet Recruiting
Cancer Hospital Affiliated to Harbin Medical UniversityHarbin, Heilongjiang, ChinaNot Yet Recruiting
Henan Cancer HospitalZhengzhou, Henan, ChinaNot Yet Recruiting

+ 20 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07379047