CTIS2023-504112-15-00进行中（未招募）1 期
A Phase 2 Open-label Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants with Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies - CA116-003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants or legally acceptable representatives who signed Written Informed Consent, Either FFPE tissue block (preferred), newly cut unstained slides or newly obtained biopsies must be available for assessment by IHC at a central laboratory prior to randomization., Participants (male or female) must be 18 years or older at the time of signing the informed consent, Participants with histologically or cytologically documented metastatic NSCLC adenocarcinoma (AC), Investigator-assessed radiologically documented disease progression during or after last treatment, Measurable target disease assessed by the investigator according to RECIST 1.1., Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of disease progression based on RECIST 1.1 to be deemed a target lesion, ECOG PS of 0 or 1, Participants must have received prior treatment, including platinumbased chemotherapy and: i) If without actionable genetic alterations or unknown genetic alterations status, treatment with anti-PD-1/PD-L1 OR ii) If with known actionable genetic alterations, treatment with at least 1 targeted therapy, Participants must have received no more than 3 prior lines of systemic therapy in the metastatic setting NOTE: Participants with resectable or stage 3 locally advanced disease that has recurred or progressed within 1 year from the start of treatment with platinumbased chemotherapy and anti-PD-1/PD-L1 are not required to be retreated in the metastatic setting to be eligible.
排除标准
- •Medical Conditions -NSCLC histologies other than adenocarcinoma (AC) -Not applicable per Protocol Amendment 2 : Pulmonary Function Test (PFT) abnormalities -Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months before treatment -Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented >6 months before starting study treatment -Current infectious pneumonia (including COVID-19-related infection), history of viral pneumonia with evidence of persistent radiologic abnormalities -Investigator assessed current ILD/pneumonitis or ILD/pneumonitis is suspected at Screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anticancer therapy -Participants with an active, known or suspected autoimmune disease, connective tissue, or inflammatory disorders with documented pulmonary involvement, Prior/Concomitant Therapy -Participants who have received prior investigational treatment with FRa-targeting agent, or FRa-targeting ADCs including MORAb-202. -Any condition requiring folate supplementation (eg, folate deficiency). -Any major surgery within 4 weeks of the first dose of study treatment, Physical and Laboratory Test Findings -Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
研究者
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