NCT07379047
尚未招募
2 期
A Multicenter, Open-label Clinical Study to Evaluate the Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 255
- 试验地点
- 37
- 主要终点
- Progression-free Survival (PFS)
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 include results on the presence or absence of KIT exon 9/11/17 mutations for randomization stratification in Part 1 and efficacy-related analyses throughout the study. The molecular pathology report indicating KIT mutation status shall be submitted to the medical monitor for review during the screening period. If a local molecular pathology report is unavailable or provides insufficient information, archived tumor tissue samples or fresh biopsy samples must be provided for central laboratory confirmation of mutation status prior to enrollment.
- •Participants with at least one measurable lesion according to mRECIST.
- •Participants with an ECOG PS of 0 to
- •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, core needle, or fine-needle aspiration).
- •Participants with an expected life expectancy of \>=12 weeks.
排除标准
- •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 prior to enrollment.
- •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 \[defined as detectable HCV-RNA by local laboratory. Participants who are HCV antibody positive at screening should have HCV-RNA tested\].
- •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 interval \>250 ms).
研究组 & 干预措施
Regorafenib
Active Comparator
160 mg QD in 28-day cycles.
干预措施: regorafenib (Drug)
NB003（part 2）
Experimental
part 2 single arm
干预措施: NB003 (Drug)
NB003
Experimental
part1 treated arm
干预措施: NB003 (Drug)
Regorafenib
Active Comparator
160 mg QD in 28-day cycles.
干预措施: NB003 (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: From randomization until database cut-off, approximately 28 months
for part 1
Objective response rate (ORR)
时间窗: approximately 24 months since the first subject enrolled
for part 2
次要结局
- Objective response rate (ORR)(From randomization until database cut-off, approximately 28 months)
- Progression-free survival (PFS)(approximately 24 months since the first subject enrolled)
- Duration of Response(DOR)(approximately 24 months since the first subject enrolled)
- Duration of Response(DOR)(approximately 28 months since the first subject enrolled)
- Overall Survival(OS)(approximately 24-36 months)
- Disease Control Rate (DCR)(Approximately 28 months since first subject enrolled)
- Disease Control Rate (DCR)(Approximately 24 months since first subject enrolled)
研究者
研究点 (37)
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