NCT06840483进行中（未招募）2 期
Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 54
- 主要终点
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the 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 NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy (see inclusion criteria below). The study will comprise of 2 cohorts. Cohort A will include participants with hormone receptor positive/ human epidermal growth factor receptor 2 negative [HR+/HER2-] breast cancer, whereas Cohort B will include participants with triple-negative breast cancer (TNBC).
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
- •Archival or fresh tumor tissue comprised of TNBC or HR+/HER2-negative invasive breast cancer available for NECTIN4 gene amplification testing.
- •Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay (CTA).
- •Measurable disease as defined by RECIST v1.
- •Life expectancy ≥ 12 weeks.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤
- •Cohort A Specific Inclusion Criteria: Histologically or cytologically confirmed HR+/HER2-negative endocrine resistant/refractory breast cancer according to ASCO-CAP guidelines and received at least 1 and up to 3 prior lines of non-endocrine-based therapy for advanced disease.
- •Cohort B Specific Inclusion Criteria: Histologically or cytologically confirmed TNBC, including ER-low positive breast cancers (1-10% of cells expressing hormonal receptors by IHC), according to ASCO-CAP guidelines and have received at least 1 and up to 3 prior lines of systemic therapy for advanced disease.
排除标准
- •Prior treatment with any antibody drug conjugate (ADC) containing an Monomethyl Auristatin E (MMAE) (vedotin) payload or other MMAE-based therapy.
- •Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
- •Previously tested HER2-positive (IHC 3+ or ISH+) on prior pathology testing (per ASCO-CAP guidelines).
- •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 drainage procedures (once 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.
- •Requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A (CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors.
- •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 (HR+/HER2-negative breast cancer)
Experimental
干预措施: Zelenectide pevedotin (BT8009) (Drug)
Cohort B (TNBC)
Experimental
干预措施: Zelenectide pevedotin (BT8009) (Drug)
结局指标
主要结局
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the 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
- Time To Progression (TTP) per RECIST v1.1 as assessed by the Investigator(Up to approximately 4 years)
- Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator(Up to approximately 3 years)
- Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator(Up to approximately 3 years)
- Overall Survival(Up to approximately 4 years)
- Progression Free Survival (PFS) per RECIST v1.1 as assessed by the Investigator(Up to approximately 3 years)
- Number of participants reporting adverse events (AEs) and Serious adverse events (SAEs)(Up to approximately 3 years)
- Duration of Response (DOR) per RECIST v1.1 as assessed by the Investigator(Up to approximately 3 years)
- Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator(Up to approximately 3 years)
- Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator(Up to approximately 3 years)
- Progression Free Survival (PFS) per RECIST v1.1 as assessed by the Investigator(Up to approximately 3 years)
- Overall Survival(Up to approximately 4 years)
- Time To Progression (TTP) per RECIST v1.1 as assessed by the Investigator(Up to approximately 4 years)
研究者
研究点 (54)
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