NCT06643754招募中1 期
A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to sign a written informed consent；
- •Age 18-70 years old (including both ends), both male and female；
- •Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
- •Existence of measurable lesions；
- •ECOG score: 0-1；
- •Expected survival time ≥ 12 weeks；
- •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, or elective surgery was expected during the trial period；
- •Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
- •Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 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
- •Arterial/venous thrombosis events occurred within 3 months prior to initial administration
- •Patients with clinical significant lung disease;
- •Patients with history of autoimmune diseases;
- •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；
- •Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.
研究组 & 干预措施
SHR-3276 for Injection will be administrated per dose level in which the patients are assigned.
Experimental
干预措施: SHR-3276 (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: up to 3 years
MTD
时间窗: up to 6 months
RP2D
时间窗: up to 1 year
次要结局
- Receptor Occupancy（OR） of SHR-3276(up to 3 years)
- Anti-drug antibody (ADA) of SHR-3276(up to 3 years)
- Objective response rate (ORR)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years)
- Duration of response (DoR)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years)
- Time to maximum concentration (Tmax)(up to 3 years)
- Maximum concentration (Cmax)(up to 3 years)
- Disease control rate (DCR)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years)
- Progression free survival（PFS）(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years)
- Overall survival (OS)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years)
研究者
研究点 (1)
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