NCT07454187招募中1 期
A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 for Injection in Patients With Relapsed/Refractory Multiple Myeloma
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-Emergent Adverse Events（AEs ）
研究概览
简要总结
The primary objective of this study was to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.
详细描述
This is a multicenter, open-label, dose-escalation and dose-expansion Phase Ib/II clinical study of SG2918 conducted in Chinese patients with relapsed/refractory multiple myeloma.The primary objective of this study is to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.Secondary objectives include exploring the efficacy, pharmacokinetic profile, pharmacodynamics, and immunogenicity of SG2918.
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
- •Age ≥ 18 years and ≤ 80 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Life expectancy ≥ 3 months.
- •Documented diagnosis of multiple myeloma.
- •Measurable disease at screening (per IMWG criteria).
- •Relevant laboratory values obtained within 7 days prior to the first dose must meet protocol-specified thresholds.
- •Resolution of adverse events related to prior antineoplastic therapy to Grade ≤ 1 or baseline (CTCAE v6.0).
- •Female participants of childbearing potential and male participants whose partners are of childbearing potential must use at least one acceptable method of contraception during study treatment and for at least 7 months after the last dose.
- •Male participants must refrain from sperm donation from the signing of the Informed Consent Form (ICF) until at least 7 months after the last study dose.
排除标准
- •Patients with primary refractory multiple myeloma.
- •Presence of non-bone-related extramedullary soft tissue plasmacytoma at screening.
- •known meningeal or Central Nervous System involvement of multiple myeloma, or high suspicion of unconfirmed meningeal or Central Nervous System involvement.
- •History of peripheral neuropathy of Grade ≥
- •Active infection requiring systemic therapy within 2 weeks prior to the first dose.
- •Hypertension that was not effectively controlled by standardized antihypertensive treatment within 2 weeks prior to the first dose, as judged by the investigator
- •History of hypertensive crisis or hypertensive encephalopathy.
- •Poorly controlled diabetes mellitus.
- •Severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose.
- •Active hepatitis B or hepatitis C infection.
- •Known history of active tuberculosis or active syphilis.
- •Known hypersensitivity to any component of the investigational product.
- •history of Grade 3-4 allergic reaction or life threatening hypersensitivity to any biological product.
- •Received any of the following therapies or surgeries.
- •Prior treatment with LILRB4 targeted therapy; or severe adverse reaction to prior MMAE containing therapy.
- •Immunotherapy, macromolecular targeted therapy, or other antineoplastic biologic therapy within 28 days prior to the first dose.
- •Cytotoxic chemotherapy or small molecule therapy within 14 days prior to the first dose.
- •Modernized traditional Chinese herbal medicine with approved antineoplastic indications within 7 days prior to the first dose.
- •Requirement for systemic corticosteroids (equivalent to > 10 mg prednisone per day) or other immunosuppressive agents within 14 days prior to the first dose or during the study.
- •Administration of any live or live attenuated vaccine within 28 days prior to the first dose.
- •Administration of other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose.
- •Immune related toxicity during prior antineoplastic immunotherapy that resulted in permanent treatment discontinuation.
- •Current or previous idiopathic pulmonary fibrosis or idiopathic pneumonia;
- •Current acute pulmonary disease, interstitial lung disease, or pneumonia.
- •Any other malignancy diagnosed within 5 years prior to the first dose.
- •Documented history of neurological or psychiatric disorder.
- •Any other condition that, in the opinion of the investigator, may render the participant unsuitable for study participation.
研究组 & 干预措施
SG2918 monotherapy
Experimental
干预措施: SG2918 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events（AEs ）
时间窗: From time Day1 of Cycle1 until 30 days after last dose of SG2918
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0
次要结局
- Pharmacokinetics(PK): Cmax(Through study completion, an average of one year)
- Pharmacokinetics (PK): T1/2(Elimination half-life of the drug after administration)
- Pharmacokinetics (PK): AUC(Through study completion, an average of one year)
- Immunogenicity(Through study completion, an average of one year)
- objective response rate(ORR)(Through study completion, an average of one year)
- PFS(Through study completion, an average of one year)
- MRD(Through study completion, an average of one year)
研究者
研究点 (4)
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