NCT05745740尚未招募1 期
An Open-label, Single-center, Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of RC48-ADC Combined With Pyrotinib in Local Advanced or Metastasis NSCLC With HER2 Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- maximal tolerance dose (MTD) of RC48-ADC combined with Pyrotinib
研究概览
简要总结
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.
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
- •Voluntary agreement to provide written informed consent.
- •Predicted survival ≥ 12 weeks.
- •According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC.
- •Is willing and able to provide an adequate archival tumor tissue sample
- •Has relapsed from or is refractory to standard treatment and had received both platinum-based therapy and immunotherapy.
- •Measurable lesion according to RECIST 1.
- •Documented HER2 exon 20 insertion mutation.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Adequate organ function.
- •For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, the blood pregnancy test within 7 days of study enrollment must be negative and must be non-lactating. Male subjects: Patients who should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study.
- •Willing and able to follow trial and follow-up procedures.
排除标准
- •No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation.
- •Patient has had previous treatment with HER2-targeted therapy prior to study participation.
- •History of major surgery within 4 weeks of planned start of trial treatment.
- •Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
- •Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- •NYHA Class III heart failure.
- •Suffering from active infection requiring systemic treatment.
- •Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD.
- •Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
研究组 & 干预措施
RC48-ADC + Pyrotinib
Experimental
干预措施: RC48-ADC (Drug)
RC48-ADC + Pyrotinib
Experimental
干预措施: Pyrotinib (Drug)
结局指标
主要结局
maximal tolerance dose (MTD) of RC48-ADC combined with Pyrotinib
时间窗: DLT will be evaluated on 28 days of observation period
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
次要结局
- Overall response rate (ORR)(Up to approximately 3 years)
- Duration of relief (DOR)(Up to approximately 3 years)
- Progression-free survival (PFS)(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 3 years)
- Disease control rate (DCR)(Up to approximately 3 years)
研究者
研究点 (1)
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