NCT05944224招募中1 期
A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 18
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in this study and sign informed consent.
- •Expected survival ≥3 months.
- •Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
- •According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
- •The laboratory test results meet the organ function requirements before starting the study treatment.
- •Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation.
- •Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.
排除标准
- •Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
- •Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.
- •Had a history of other malignancies before starting the study.
- •History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
- •Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.
- •Previous history of organ transplantation.
- •Before starting the study, HBsAg positive patients with HBV DNA > 500IU/ mL or 2500 copies /mL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis.
- •Accompanied by any other serious, progressive, or uncontrolled disease.
- •Subjects with a known history of immune-related adverse events that the investigator determined could not be included.
- •History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.
- •Women who are pregnant or breastfeeding.
- •Any other reason for which patients are ineligible for the study as assessed by the investigator.
研究组 & 干预措施
SPH4336
Experimental
干预措施: SPH4336 (Drug)
SPH4336+ Cadonilimab
Experimental
干预措施: Cadonilimab (Drug)
SPH4336+ Cadonilimab
Experimental
干预措施: SPH4336 (Drug)
Cadonilimab
Experimental
干预措施: Cadonilimab (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Approximately 2 years
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
次要结局
- Objective response rate (ORR)(Approximately 2 years)
- Cmax(Approximately 2 years)
- progression-free rate（PFR）(Approximately 2 years)
- Disease control rate (DCR)(Approximately 2 years)
- Duration of remission (DOR)(Approximately 2 years)
- Overall Survival (OS)(Approximately 8 years)
- Incidence of Adverse event(Approximately 2 years)
- Tmax(Approximately 2 years)
研究者
研究点 (18)
Loading locations...
相似试验
终止
2 期
Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic LiposarcomasLiposarcoma, DedifferentiatedNCT05580588Shanghai Pharma Biotherapeutics USA Inc.14
已完成
1 期
Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid TumorsAdvanced Solid TumorsNCT05905614Shanghai Pharmaceuticals Holding Co., Ltd29
撤回
2 期
A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SM04646 Inhalation Solution in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisNCT03591926Biosplice Therapeutics, Inc.
招募中
3 期
SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian CancerOvarian CancerNCT06394492Suzhou Suncadia Biopharmaceuticals Co., Ltd.440
进行中（未招募）
3 期
Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLCALK-positiveSAF-189sNon-Small Cell Lung CancerNCT06569420Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.275