NCT06883630进行中（未招募）1 期
A Phase Ib, Multi-Cohort, Open-Label, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of RC148 Injection as Monotherapy or Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 121
- 试验地点
- 24
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of RC148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer
详细描述
Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;
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
- Single (Participant)
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
- •Voluntarily participate in the study and signed the ICF;
- •Be willing to and able to act on the trial and the follow up procedures;
- •Male or female, aged 18-80 years;
- •Expected survival ≥ 3 months;
- •ECOG PS score 0 or 1;
- •All participants to be enrolled in cohorts 1-5 must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced or metastatic NSCLC (stage IIIB//IIIC/IV according to the 8th edition of UICC/AJCC) and not amendable to curative surgery or radiation as assessed by investigator.
排除标准
- •Histopathologically or cytologically confirmed small cell lung cancer;
- •Received major surgeries and still in recovery within 28 days before the first dose;
- •Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study (except for COVID-19 vaccine);
- •Received immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor treatment within 28 days prior to the first dose, or experienced prior permanent immunotherapy discontinuation due to immunotoxicity;
- •Participated in other clinical trials and received other investigational anti-tumor therapy within 28 days prior to the first dose;
- •Poor compliance and unable to complete the study procedures as assessed by investigator;
- •Have any other medical conditions, abnormal physical examinations or laboratory examinations that would be suspected interfere with participation or evaluation of the trial or increase the risk to the participant, in view of the investigator.
研究组 & 干预措施
AGA-, NSCLC without systemic therapy
Experimental
Combination Therapy
干预措施: RC148 plus Carboplatin and Paclitaxel/pemetrexed (Drug)
AGA-，PD-1+, NSCLC without systemic therapy
Experimental
Monotherapy
干预措施: RC148 (Drug)
EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment
Experimental
Combination Therapy
干预措施: RC148 plus Carboplatin and Paclitaxel/pemetrexed (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 24 months
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
次要结局
- Disease Control Rate (DCR)(24 months)
- Duration of Response (DOR)(24 months)
- Progression-free survival (PFS)(24 months)
- Overall survival (OS)(24 months)
- Number of participants with adverse events (AEs)(24 months)
- Incidence of RC148 anti-drug antibody (ADA)(24 months)
- Maximum observed concentration (Cmax) of RC148(24 months)
研究者
研究点 (24)
Loading locations...
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