NCT05431569Unknown2 期
A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer Who Had Failed Therapy With PD-1/L1 Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 主要终点
- ORR
研究概览
简要总结
A non-randomized, open, Simon'soptimal2-stage study to evaluate the efficacy and safety of 6MW3211 in patients with advanced Lung Cancer who had failed therapy with PD-1/L1 Inhibitor.
详细描述
36 to 64 patients with advanced lung cancer who failed pD-1 /L1 inhibitor treatment will be inrolled.
Cohort 1:20 to 33 patients with non-small cell lung cancer (NSCLC) Cohort 2:16 to 31 patients with small cell lung cancer (SCLC)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cohort1：Locally advanced or metastatic NSCLC (stage IIIB-IV) confirmed by histological or cytological evidence that cannot be treated with radical surgical resection and cannot be treated with radical synchronous/sequential chemoradiotherapy.
- •cohort2:Extensive stage small cell lung cancer (ES-SCLC) confirmed byhistologically or cytologically 3.Patients who had failed therapy with PD-1/L1 Inhibitor. 4.≥5 slides of unstained tumor tissue should be provided 5.EGFR, ALK, ROS1 were negative 6.ECOG 0 or 1 7.At least one extracranial measurable target evaluated by RECIST1.1 8.Expected survival≥3 months 9.Suitable organs and hematopoietic functions 10.Women and men of reproductive age must agree to use effective contraception from the date of signing the informed consent until 6 months after the last administration of 6MW3211 injection, and women of reproductive age must have negative serum pregnancy test results within 7 days prior to administration.
- •11.Sign informed consent voluntarily
排除标准
- •Patients who had received immunotherapy other than pD-1 /L1 inhibitors
- •Patients who were discontinued due to grade ≥3 serious immune-related adverse events (irAE) when treated with a PD-1/L1 inhibitor
- •Patients who had received anti-PD-1 /L1 inhibitor,have had immune pneumonia or immune myocarditis
- •Patients who had malignant tumors other than NSCLC or SCLC within 5 years
- •Patients with active central nervous system (CNS) metastasis or meningeal metastasis.
- •Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1
- •patients with autoimmune diseases that are likely to recur
- •Patients with history of interstitial lung disease or have non-infectious pneumonia
- •Uncontrolled systemic diseases after treatment.
- •Patients with active tuberculosis
- •Patients with severe infection or requiring antibiotic treatment within the first 4 weeks prior to initial administration
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- •Prior blood transfusion or hematopoietic stimulator therapy within 4 weeks prior to initial dosing
- •Patients who have previously received antitumor therapy
- •Patients requiring systemic glucocorticoids or other immunosuppressive agents within 14 days prior to initial dosing or during the study period
- •Patients who were allergic to any composition of investigational drug
- •Patients with chronic active hepatitis B or active hepatitis C
- •Patients who received other investigational drugs within 4 weeks prior to initial dosing
- •Patients who underwent major surgery within 30 days prior to first administration
- •History of drug or substance abuse in the past 1 year
- •Live vaccine was administered within 30 days prior to first administration
- •Have the history of neuropsychiatric disorders
- •Women who are pregnant or breastfeeding
- •Patients had other factors that might have forced them to terminate the study by investigator's judgment -
研究组 & 干预措施
6MW3211
Experimental
6MW3211injection,30mg/kg,Q2W
干预措施: 6MW3211 (Drug)
结局指标
主要结局
ORR
时间窗: up to 24mouths or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on
The percentage of (PR+CR) after treatment to the total number of cases was calculated
次要结局
未报告次要终点
研究者
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