NCT07028281招募中2 期
A Multicenter, Open-label, Phase II Clinical Study of SHR-4849 Injection Combined With Other Antineoplastic Drugs in Patients With Malignant Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent prior to initiation of any study-procedures
- •Age from 18 to 75 years old at the time of signing the informed consent
- •Histologically or cytologically confirmed solid tumors
- •At least one measurable lesion was identified per RECIST 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Has a life expectancy of at least 3 months.
- •Adequate organ function
- •Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 8 months after the last dose of the trial drug
排除标准
- •Subjects with active central nervous system (CNS) metastasis.
- •Subjects with a history of malignant tumors within 5 years prior to the first dose
- •Subjects with uncontrolled cancer pain.
- •Subjects with severe cardiovascular disease.
- •Subjects with clinically significant hemorrhage
- •Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
- •Subjects highly suspected of interstitial lung disease
- •Subjects with serious infection within 4 weeks prior to the first dose
- •Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
- •The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
- •Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
- •Subjects who received major surgery within 4 weeks prior to the first dose
- •Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
- •Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
- •Known allergic to any component of investigational drugs
- •Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
- •Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin (Drug)
结局指标
主要结局
DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage)
时间窗: up to 21 days
Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The first stage)
时间窗: up to 24 months
Objective Response Rate (ORR) as Assessed by investigators(The second stage)
时间窗: up to 24 months
次要结局
- ORR(The first stage)(up to 24 months)
- DoR(The first stage)(up to 24 months)
- DCR(The first stage)(up to 24 months)
- PFS(The first stage)(up to 24 months)
- OS(The first stage)(up to 30 months)
- DoR(The second stage)(up to 24 months)
- DCR(The second stage)(up to 24 months)
- PFS(The second stage)(up to 24 months)
- OS(The second stage)(up to 30 months)
- Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The second stage)(up to 24 months)
研究者
研究点 (1)
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