NCT07490613招募中1 期
An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3836 in Patients With Multiple Myeloma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Determination of Phase II Dose (RP2D) of SHR-3836
研究概览
简要总结
This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-3836 in patients with multiple myeloma (MM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Age ≥ 18 years, male or female
- •Expected survival ≥ 3 months
- •ECOG performance status 0 or 1
- •Diagnosed with active multiple myeloma per IMWG criteria
- •Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.
- •Disease progression or non-response to the most recent therapy
- •Measurable disease as defined by serum/urine M-protein or serum free light chain
- •Adequate bone marrow, hepatic, renal, and coagulation function
- •Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception
- •Willing and able to provide written informed consent and comply with study procedures
排除标准
- •Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
- •Central nervous system involvement by tumor.
- •History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.
- •Requirement for dialysis or plasmapheresis within 14 days prior to study drug.
- •Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).
- •Concurrent participation in another clinical study.
- •Prior anti-tumor therapy within specified washout periods.
- •Major surgery within 28 days prior to informed consent or planned during the study.
- •Live attenuated vaccine within 4 weeks prior to first dose or planned during the study.
- •Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.
- •Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo).
- •Active infection.
- •Known hypersensitivity or contraindication to SHR-3836.
研究组 & 干预措施
SHR-3836 for injection
Experimental
干预措施: SHR-3836 administered as multiple doses. (Drug)
结局指标
主要结局
Determination of Phase II Dose (RP2D) of SHR-3836
时间窗: 24 months
次要结局
- Incidence and severity of adverse events (AE) of SHR-3836(24 months)
- Maximum plasma concentration (Cmax)(24 months)
- Time to reach Cmax (Tmax)(24 months)
- Objective response rate (ORR)(24 months)
研究者
研究点 (1)
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