NCT06527300招募中2 期
A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents with Advanced NUT Cancer
Zhejiang Wenda Medical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年4月25日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multicenter, open-label, single-arm, phase II study to evaluate the efficacy, safety, and pharmacokinetics of NHWD-870 HCl in adults and adolescents with advanced NUT cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A written informed consent signed;
- •Subjects must sign and date IEC-approved written informed consent in accordance with the guidelines of the competent authorities and research institutions. Informed consent had to be obtained before any protocol-related procedure that was not part of a participant's routine care was performed.
- •Participants must be willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study;
- •If the subjects were under 18, the participants and their legal guardian authorization signed agreement;
- •Both sexes, the first part (adult group) was ≥18 years old and ≤75 years old, the second part (adolescent group) was ≥12 years old and <18 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- •The expected survival period for 3 months or more;
- •The histopathological (histopathological diagnosis was the first time according to the tumor tissue pathologic specimens before three years, if more than 3 years should be confirmed in the center of the study to do a biopsy. If, in the investigator's judgment, a biopsy might increase a subject's risk, archival tumor tissue samples up to 3 years old could be collected after discussion with the sponsor) were diagnosed as midline (NUT) cancer by, but not limited to:
- •Determination of ectopic NUT protein expression by IHC;
- •Detection of NUT gene translocations by fluorescence in situ hybridization (FISH);
- •Detection of NUT gene translocations (e.g. BRD3/4 mutation or ≥ 2-fold amplification) by DNA/RNA sequencing.
排除标准
- •Prior treatment with a BET inhibitor;
- •3 years before into the group suffering from other malignant tumors, with the exception of removal of cure of basal cell carcinoma, orthotopic bladder cancer or cervical carcinoma in situ;
- •The researchers believe the subjects is the need for systemic anti-infection treatment of active infection;
- •Patients with clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.
- •Imaging shows that the tumor has invaded important blood vessels or the investigators judge that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study.
研究组 & 干预措施
Adult：NHWD-870 HCl 2mg ； Adolescent：NHWD-870 HCl 1.5mg/2mg
Experimental
Take a fixed dose of NHWD-870 HCl tablets orally.
干预措施: NHWD-870 HCl (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Completed at least four weeks of treatment, the curative effect evaluation of CR, PR and maintain at least 4 weeks, the proportion of the subjects,up to 5 months;
次要结局
- Disease control rate (DCR)(Completed at least four weeks of treatment,tumor curative effect evaluation of CR, PR and SD proportion of subjects,up to 5 months;)
- time to remission (TTR)(From the beginning the study drug therapy to ease for the first time (including patients with CR and PR),up to 5 months.)
- Duration of response (DoR)(Completed at least four weeks of treatment,first time participants from CR or PR to onset of disease (PD),up to 5 months;)
- Progression-free survival (PFS)(From start studying drug therapy to the disease progression or any reason for the first time the time of death,up to 12 months;)
研究者
研究点 (1)
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