NCT06131216尚未招募1 期
Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-2022 Injection Alone or in Combination With Other Anti-tumor Treatments in Patients With Advanced Malignant Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 116
- 主要终点
- Severity of adverse events
研究概览
简要总结
To evaluate the safety and tolerability of SHR-2022 in patients with advanced malignancies and to determine MTD or MAD versus RP2D
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up
- •Age 18-80 years old (including both ends), both male and female
- •Subjects with advanced or metastatic malignant tumors confirmed by pathological tissue or cytology, and who have failed previous standard treatments, are intolerant to standard treatments, or have no standard treatments
- •Have measurable lesions
- •ECOG PS score: 0-1
- •Have a life expectancy of at least 3 months
- •The functional level of the major organs must meet the requirements
- •Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating
排除标准
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms
- •Spinal cord compression that has not been treated radically by surgery and/or radiotherapy
- •Patients with uncontrolled tumor-related pain as judged by the investigator
- •A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator
- •Systemic antitumor therapy was administered within 28 days prior to treatment in the first study
- •Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period
- •Received within 28 days prior to the first investigational dose Non-radical chest radiation therapy of 30Gy received within 24 weeks prior to initial dosing. Patients receiving 30Gy of chest radiation therapy, and those receiving palliative radiation ≤30Gy within 14 days prior to the first dose
- •The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤1
- •Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment
- •Systemic immunosuppressive therapy was administered within 14 days prior to the first study
- •Accompanied by interstitial pneumonia or interstitial lung disease
- •Patients with a history of autoimmune disease
- •The first study studied patients with clinically significant bleeding symptoms or bleeding tendency within 3 months before medication
- •The first study was conducted in subjects with severe cardiovascular and cerebrovascular disease within 6 months prior to medication
- •Arterial/venous thrombosis events occurred within 3 months prior to initial administration
- •The first study studied any other malignancy within 5 years prior to medication
- •A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients
- •Have a history of immune deficiency or organ transplantation, and have active hepatitis B or C
- •Severe infection within 4 weeks prior to the first dose
- •Patients with active pulmonary tuberculosis within 1 year prior to enrollment were found by history or CT examination
- •The presence of other serious physical or mental illness, known alcohol or drug dependence, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study
研究组 & 干预措施
SHR-2022 Injection
Experimental
干预措施: SHR-2022 Injection (Drug)
结局指标
主要结局
Severity of adverse events
时间窗: up to 3 years
MTD
时间窗: up to 3 years
Incidence of adverse events
时间窗: up to 3 years
RP2D
时间窗: up to 3 years
次要结局
- Maximum concentration (Cmax)(up to 3 year)
- Receptor Occupancy（OR） of SHR-2022(up to 3 year)
- Time to maximum concentration (Tmax)(up to 3 year)
- Anti-drug antibody (ADA) of SHR-2022(up to 3 year)
- Objective response rate (ORR)(up to 3 year)
研究者
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