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Tests treatment safety and results for GIST - Gastrointestinal Stromal Tumor
Official title Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
ClinicalTrials.gov ID: NCT07379047
What this study is testing
What is NB003?
NB003 is an investigational medicine, being studied as a potential treatment for gist - gastrointestinal stromal tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants are \>=18 years of age (or the legal adult age as per local regulations, whichever is older) at the time of signing the ICF.
- Participants, or legally authorized representatives permitted by local regulations, provide written informed consent for participation in the study.
- Participants who have histologically confirmed locally advanced, unresectable, or metastatic GIST.
- Part 1: Patients who have failed prior treatment with imatinib (including adjuvant therapy) and sunitinib for GIST due to disease progression or...
- Part 2: Patients who have failed prior treatment with imatinib (including adjuvant therapy) for GIST due to disease progression or intolerance...
You likely can't join if
- Part 1: Participants who have received prior treatment with NB003 or regorafenib. Part 2: Participants who have received prior treatment with NB003...
- Participants who have received any systemic anti-tumor therapy within 7 days prior to enrollment.
- Participants who have undergone major surgery (excluding vascular access placement, tumor biopsy, and feeding tube placement) or major palliative...
- Participants who have received radiation therapy to \>30% of the bone marrow or extensive radiation therapy within 4 weeks prior to enrollment.
- Active infection, including active hepatitis B [defined as detectable HBV-DNA by local laboratory. Participants who are HBsAg positive or HBcAb...
- Any of the following cardiac-related criteria:
See the full eligibility criteria
Who can join
- Participants are \>=18 years of age (or the legal adult age as per local regulations, whichever is older) at the time of signing the ICF.
- Participants, or legally authorized representatives permitted by local regulations, provide written informed consent for participation in the study.
- Participants who have histologically confirmed locally advanced, unresectable, or metastatic GIST.
- Part 1: Patients who have failed prior treatment with imatinib (including adjuvant therapy) and sunitinib for GIST due to disease progression or intolerance. Participants should also have no prior use of other TKI drugs.
- Part 2: Patients who have failed prior treatment with imatinib (including adjuvant therapy) for GIST due to disease progression or intolerance. Participants should also have no prior use of other TKI drugs.
- Participants with confirmed KIT gene mutation based on local or central laboratory molecular pathology reports. Mutation status must be determined using tissue-based PCR or DNA sequencing methods. The report should...
- Participants with at least one measurable lesion according to mRECIST.
- Participants with an ECOG PS of 0 to 1.
- Tumor sample requirement: Archival tumor samples in the form of formalin-fixed paraffin-embedded (FFPE) tissue sections or FFPE blocks obtained prior to enrollment, or tissue samples from a tumor biopsy (excisional...
- Participants with an expected life expectancy of \>=12 weeks.
- Participants shall have adequate organ and bone marrow function. Transfusions and/or treatment with erythropoietin and/or granulocyte colony stimulating factor/granulocyte macrophage colony stimulating factor...
- Hemoglobin \>=9 g/dL (5.59 mmol/L).
- Absolute neutrophil count (ANC) \>=1.5 x 10\^9/L (1500/mm\^3).
- Platelet count \>=100 x 10\^9/L (100,000/mm\^3).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 2.5 x upper limit of normal (ULN) (for participants without liver metastases); AST and ALT \<= 5 x ULN (for participants with liver metastases).
- Total bilirubin \<=1.5 x ULN. Participants with a confirmed diagnosis of Gilbert's syndrome (persistent or recurrent unconjugated hyperbilirubinemia in the absence of hemolysis or hepatic pathology) may be enrolled if...
- Creatinine clearance \>=60 mL/min as calculated by the Cockcroft-Gault formula or 24-hour urine collection.
- International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) \<=1.5 x ULN; however, if a participant is receiving anticoagulant therapy, PT or aPTT within the...
- Male participants: Male participants must agree to use contraception as detailed in Appendix 9 during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm...
- Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i) She is not a woman of childbearing potential...
- WOCBP must have a negative serum pregnancy test result during screening within 14 days prior to enrollment.
What rules you out
- Part 1: Participants who have received prior treatment with NB003 or regorafenib. Part 2: Participants who have received prior treatment with NB003 or sunitinib.
- Participants who have received any systemic anti-tumor therapy within 7 days prior to enrollment.
- Participants who have undergone major surgery (excluding vascular access placement, tumor biopsy, and feeding tube placement) or major palliative interventions (such as transarterial chemoembolization) within 4 weeks...
- Participants who have received radiation therapy to \>30% of the bone marrow or extensive radiation therapy within 4 weeks prior to enrollment.
- Active infection, including active hepatitis B [defined as detectable HBV-DNA by local laboratory. Participants who are HBsAg positive or HBcAb positive at screening should have HBV-DNA tested] and active hepatitis C...
- Any of the following cardiac-related criteria:
- Uncontrolled persistent (\>4 weeks) hypertension (\>140/90 mmHg).
- New York Heart Association (NYHA) Class (Appendix 11) III and IV heart disease, active ischemia, or other uncontrolled cardiac conditions such as angina.
- QTc interval Corrected QT interval using Fridericia's formula (QTcF) \>=470 ms (based on 3 ECG results) or history of long QT syndrome.
- Resting ECG showing any clinically significant abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, atrioventricular block third degree, atrioventricular block second degree, PR...
- Left ventricular ejection fraction (LVEF) \<50%.
- Any unresolved prior treatment toxicity greater than CTCAE Grade 1 at the start of study treatment, with the exception of alopecia, hemoglobin (see Inclusion Criterion #10), Grade 2 hypothyroidism stable on hormone...
- Participants who have experienced a National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 Grade 3 or higher bleeding event within 4 weeks prior to enrollment.
- Participants who have experienced an arterial thrombotic or embolic event (e.g., cerebrovascular accident, including transient ischemic attack) within 6 months prior to enrollment, or a venous thrombotic event...
- Participants who have experienced a seizure for any reason within 6 months prior to enrollment.
- Participants with known bleeding disorders or risk of intracranial hemorrhage (e.g., unexcised or unrepaired cerebral aneurysm, cerebrovascular malformation), or history of intracranial hemorrhage within 1 year prior to...
- Participants with unhealed wounds, active ulceration, gastrointestinal perforation, or fracture within 3 months prior to enrollment.
- Participants with brain metastases.
- History of pancreatitis with prior tyrosine kinase inhibitors use, or current evidence of mild to moderate pancreatitis.
- Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulation, or significant bowel resection that may affect adequate absorption of NB003 and regorafenib.
- Any other clinically significant comorbidity, such as uncontrolled lung disorder, active infection, uncontrolled pericardial effusion, uncontrolled pleural effusion, or any other condition that, in the investigator's...
- Participants judged by the investigator to be unwilling or unable (including incompetence) to comply with study procedures, restrictions, and requirements.
- Participants currently using (or unable to discontinue at least 2 weeks prior to enrollment) drugs or herbal supplements known to be strong inhibitors or inducers of CYP3A4, and other prohibited concomitant medications...
- History of hypersensitivity to the active or inactive ingredients of NB003, regorafenib, or drugs with similar chemical structure or class to NB003 or regorafenib.
- History of other primary neoplasm malignant diagnosed or requiring treatment within 3 years prior to enrollment. The following prior malignancies are not exclusion criteria: completely resected basal cell and squamous...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guandong, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Jinan, Shandong, China
- Qingdao, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guandong, China; Guangzhou, Guangdong, China and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.