NCT06752746招募中1 期
A Phase Ib, Multicenter, Randomized, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- Vital sign
研究概览
简要总结
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of 9MW3011 in Chinese patients with Polycythemia Vera（PV）.
详细描述
The multiple dose fo the starting dose cohorts will comprise 3 dose cohorts of 8 PV subjects each.In each cohort, subjects will receive 9MW3011 via intravenous infusion.A decision on whether to proceed with case expansion and dose escalation will be based on the safety and PK-PD data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male and female patients aged 18 years or older at the time of screening.
- •A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria and are resistant to or intolerant of hydroxyurea or Interferon alpha.
- •Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha.
- •Subjects receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug.
- •Must agree to adhere to appropriate contraception requirements during the study period.
- •All female subjects with fertility capacity tested negative for blood pregnancy.
- •Voluntarily participate in clinical trials and agrees to participate in the study by giving written informed consent.
排除标准
- •The spleen is palpable at least 5 centimeters below the left costal margin upon palpation at baseline.
- •Heart failure, unstable angina pectoris, myocardial infarction, and other thrombotic diseases within the 6 months prior to screening.
- •Abnormal QTc interval of electrocardiogram within the 6 months prior to screening.
- •Uncontrolled hypertension prior to screening.
- •Any non-PV myeloproliferative neoplasms (MPN).
- •Blast cells and blast granulocytes in the peripheral blood within the 3 months prior to screening.
- •Hematological indicators do not meet the requirements at the time of screening.
- •Known positive for active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus (HIV) infection.
- •History of invasive malignancies within the last 5 years.
- •Severe infection or uncontrolled active infection.
- •Other hematological and lymphatic system diseases or any diseases causing hemolysis or erythrocyte instability.
- •Other systemic diseases or a family history of systemic diseases, may affect the subject's safety or any other diseases and physiological conditions that may affect the results of the study, judged by the investigator.
- •Specific history of allergies.
- •Subjects who have used monoclonal antibodies within the 6 months prior to screening.
- •Patients who have received vaccinations within 6 weeks prior to screening.
- •Subjects who have received other antitumor therapeutic drugs for PV prior to screening.
- •Chronic diseases requiring treatment with systemic glucocorticoids or other immunosuppressants.
- •History of drug abuse or illicit drug use within 3 months prior to screening.
- •Participation in other clinical trials within 3 months prior to screening.
- •Planned elective surgery during the study.
- •History of surgery within 3 months prior to screening.
- •Intolerable iron deficiency-related symptoms judged by the investigator prior to the first dosing.
- •Pregnant or lactating females; women of reproductive age who are not using effective contraception.
- •Individuals directly associated with the research and/or their immediate family members.
- •Other factors which may potentially affect the assessment of the study results by the investigator.
研究组 & 干预措施
Experimental: Open-label 9MW3011 Dose1
Experimental
Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion
干预措施: 9MW3011 (Drug)
Experimental: Open-label 9MW3011 Dose2
Experimental
Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion
干预措施: 9MW3011 (Drug)
Experimental: Open-label 9MW3011 Dose3
Experimental
Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion
干预措施: 9MW3011 (Drug)
结局指标
主要结局
Vital sign
时间窗: Up to 141 or 197 days
Incidence of treatment-emergent clinically abnormal vital signs
Physical examination
时间窗: Up to 141 or 197 days
Incidence of treatment-emergent clinically abnormal physical examinations
12-lead electrocardiogram (ECG)
时间窗: Up to 141 or 197 days
Incidence of treatment-emergent clinically significant 12-lead electrocardiograms (ECGs)
Laboratory test result
时间窗: Up to 141 or 197 days
Incidence of treatment-emergent clinically significant laboratory test results
Adverse Event
时间窗: Up to 141 or 197 days
Incidence of adverse events
次要结局
- Cmax(Day 1 to Day 141 or 197)
- Tmax(Day 1 to Day 141 or 197)
- AUC0-τ(Day 1 to Day 141 or 197)
- AUC0-t(Day 1 to Day 141 or 197)
- AUC0-∞(Day 1 to Day 141 or 197)
- λz(Day 1 to Day 141 or 197)
- t1/2z(Day 1 to Day 141 or 197)
- MRT(Day 1 to Day 141 or 197)
- Vss(Day 1 to Day 141 or 197)
- CLss(Day 1 to Day 141 or 197)
- DF(Day 1 to Day 141 or 197)
- Ctrough(Day 1 to Day 141 or 197)
- Serum iron(Day 1 to Day 141 or 197)
- Transferrin saturation (TSAT)(Day 1 to Day 141 or 197)
- Rac(AUC)(Day 1 to Day 141 or 197)
- Rac(cmax)(Day 1 to Day 141 or 197)
- Hepcidin(Day 1 to Day 141 or 197)
- Anti-drug antibodies(ADA)(Day 1 to Day 141 or 197)
- Hematocrit (HCT)(Day1 to Day 141 or 197)
- Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score（MPN-SAF TSS）(Day 1 to Day 141 or 197)
研究者
研究点 (6)
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