NCT06933329进行中（未招募）2 期
Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 73
- 试验地点
- 14
- 主要终点
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) assessed by Investigator
研究概览
简要总结
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated NECTIN4-amplified advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior line of systemic therapy in the advanced/metastatic setting (see inclusion criteria below). The study will comprise of 2 cohorts: Cohort A (non-squamous NSCLC) and Cohort B (squamous NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically or cytologically confirmed advanced or metastatic NSCLC.
- •Cohort A: Histologically or cytologically confirmed non-squamous NSCLC.
- •Cohort B: Histologically or cytologically confirmed squamous NSCLC.
- •Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay.
- •Participants must have received at least 1 prior line of systemic therapy in the advanced/metastatic setting.
- •Participants with no known actionable genomic alterations must have received both platinum based therapy and immunotherapy given either sequentially or in combination for advanced/metastatic NSCLC. Must not have received more than 3 prior lines of systemic therapy in the advanced/metastatic setting.
- •Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy in the advanced/metastatic setting.
- •Measurable disease as defined by RECIST v1.
- •Adequate archival or fresh tumor tissue comprised of advanced or metastatic NSCLC should be available for submission to central laboratory, if not provided during prescreening.
- •Life expectancy ≥ 12 weeks.
- •Eastern Cooperative Oncology Group Performance Status of ≤
排除标准
- •Evidence of mixed small cell lung cancer (SCLC) and NSCLC histology.
- •Prior treatment with monomethyl auristatin E (MMAE) (vedotin) based therapy.
- •Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
- •Ongoing clinically significant toxicity (Grade ≥ 2) associated with prior treatment for NSCLC (including radiotherapy or surgery), with the exception of well-controlled immuno-oncology related endocrine disorders on supportive or replacement therapy, and alopecia. (Note: Immunosuppressive therapies should be stopped or tapered down to ≤10 mg/day prednisone or equivalent before first study drug administration.)
- •Active keratitis or corneal ulcerations.
- •Active or untreated central nervous system (CNS) metastases.
- •Uncontrolled diabetes or hypertension.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent draining procedures (monthly or more frequently).
- •Active interstitial lung disease or pneumonitis requiring ongoing treatment with steroids (>10mg/day of prednisone or equivalent) or other immunosuppressive medications; or any prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
- •History of another active malignancy, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other malignancies curatively treated with no evidence of disease for ≥3 years.
- •Known requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A ([cytochrome P450 3A] CYP3A) including herbal- or food-based inhibitors/inducers.
- •Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment.
- •Note: Additional protocol defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
Cohort A (non-squamous NSCLC)
Experimental
干预措施: Zelenectide pevedotin (Drug)
Cohort B (squamous NSCLC)
Experimental
干预措施: Zelenectide pevedotin (Drug)
结局指标
主要结局
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) assessed by Investigator
时间窗: Up to approximately 3 years
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
次要结局
- Overall Survival (OS)(Up to approximately 3 years)
- Number of participants reporting adverse events (AEs) and abnormalities in laboratory, electrocardiogram (ECG) and vital signs(Up to approximately 3 years)
- Duration of Response (DOR) per RECIST v1.1 assessed by the Investigator(Up to approximately 3 years)
- Disease Control Rate (DCR) per RECIST v1.1 assessed by the Investigator(Up to approximately 3 years)
- Clinical Benefit Rate (CBR) per RECIST v1.1 assessed by the Investigator(Up to approximately 3 years)
- Progression Free Survival (PFS) per RECIST v1.1 assessed by the Investigator(Up to approximately 3 years)
- Time to Progression (TTP) per RECIST v1.1 assessed by the Investigator(Up to approximately 3 years)
研究者
研究点 (14)
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