Condition: GIST - Gastrointestinal Stromal Tumor · Advanced · Sponsor: Ningbo Newbay Technology Development Co., Ltd
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.
Zhi Zhang · +86-21-68880576 · zzhang@newbaypharma.com
Always discuss trial participation with your own doctor first.
| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Not Yet Recruiting |
| The Second Hospital of Anhui Medical University | Hefei, Anhui, China | Recruiting |
| Beijing Cancer Hospital | Beijing, Beijing Municipality, China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality, China | Not Yet Recruiting |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou, Fujian, China | Not Yet Recruiting |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guandong, China | Not Yet Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou, Guangdong, China | Not Yet Recruiting |
| Guangxi Medical University Affiliated Cancer Hospital | Nanning, Guangxi, China | Not Yet Recruiting |
| The Affiliated Hospital of Guizhou Medical University | Guiyang, Guizhou, China | Not Yet Recruiting |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang, Hebei, China | Not Yet Recruiting |
| Cancer Hospital Affiliated to Harbin Medical University | Harbin, Heilongjiang, China | Not Yet Recruiting |
| Henan Cancer Hospital | Zhengzhou, Henan, China | Not Yet Recruiting |
+ 20 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07379047