NCT06781567招募中2 期
A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants with Recurrent or Metastatic Adenoid Cystic Carcinoma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- HitGen Inc.
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
This is a Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed informed consent form (ICF) and able to comply with study.
- •Age ≥18 years, gender unlimited.
- •Recurrent or metastatic adenoid cystic carcinoma with evidence of disease progression (imaging progression or clinical evidence of progression) within one year of histological or cytological diagnosis.
- •Estimated survival >12 weeks, as determined by the investigator.
- •The United States Eastern Cancer Consortium (ECOG) physical status score 0-
- •Has adequate organ function.
- •At least 1 measurable tumor lesion according to RECISTv1.1 criteria.
排除标准
- •Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
- •Received prior therapies targeting HDAC.
- •Chemotherapy was received within 21 days before the first administration of the study treatment, and anti-tumor therapy such as radiotherapy, biotherapy, targeted therapy, and immunotherapy was received within 28 days before the first administration of the study treatment [small molecule targeted drugs, Chinese medicines with anti-tumor indications, and local palliative radiotherapy were 14 times before the first administration of the study drug.
- •Used strong CYP3A4 inhibitors or inducers within 7 days before the first use of the investigational drug.
- •Major surgery or major injury <=28 days before the first dose of study treatment,or anticipated major surgery during the study.
- •Prior allogeneic bone marrow transplantation or other solid organ transplantation
- •Active infection requiring systemic treatment.
- •Current or past presence of other malignancies (other than adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix), unless radical treatment has been performed and there is no evidence of recurrence and metastasis in the last 5 years.
- •A person is known to be allergic to any active ingredient or excipient of the investigational drug.
- •Pregnant or lactating women.
- •patients with drug abuse or chronic alcohol abuse that may affect the evaluation of the test results.
研究组 & 干预措施
Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma
Experimental
Experimental: HG146 Monotherapy Arm Description: Participants will receive HG146 per os at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle.
干预措施: HG146 (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: From enrollment to the end of treatment at 4 weeks
ORR will be assessed by the investigators using RECIST v1.1
6 Months Progression-Free Survival （PFS）
时间窗: From enrollment to treatment at 6 months.
PFS will be assessed by the investigators using RECIST v. 1.1
次要结局
- Progression-Free Survival （PFS）(From enrollment to treatment at 12 months)
- Duration of response (DoR)(From enrollment to the end of treatment at 4 weeks)
- Disease control rate (DCR)(From enrollment to the end of treatment at 4 weeks)
- Overall survival (OS)(From enrollment to the end of treatment at 4 weeks)
- Time-to-response (TTR)(From enrollment to the end of treatment at 4 weeks)
- Population pharmacokinetics (PopPK)(From Cycle1 Day7 to Day13, 21 days per cycle)
研究者
研究点 (1)
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