NCT06908928招募中1 期
An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 10
- 主要终点
- Objective Response Rate
研究概览
简要总结
The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.
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
- 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
- •Patient has measurable disease by RECIST v1.1
- •Recurrent or metastatic triple-negative breast cancer patients as per current ASCO/CAP guidelines
- •Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload.
- •Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.
- •Provision of archival tumor tissue or fresh tumor biopsy.
- •Capable of giving informed consent
- •Male or female subjects aged ≥ 18 years.
- •Subjects must be willing to receive blood transfusions if medically indicated.
- •Adequate hematologic and organ function
- •Life expectancy of at least 3 months as assessed by the investigator
- •Compliance with contraceptive requirement
排除标准
- •Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates.
- •Unstable CNS metastasis requiring treatment in the last 28 days.
- •Acute infection requiring IV treatment in the last 14 days.
- •Grade ≥2 peripheral neuropathy.
- •Pregnant or breastfeeding women.
- •Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk
- •Any systemic anticancer therapy in the last 28 days prior to first administration of study drug.
- •Active HCV, HBV or HIV infection unless well controlled with anti-viral therapy.
- •Active or chronic corneal disorder, keratitis, corneal ulcerations or Sjogren's syndrome.
- •Have any ongoing acute inflammatory skin disease or chronic skin disease not well controlled.
- •Have been diagnosed with another primary malignancy except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or subjects with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
- •Have significant, uncontrolled or active cardiovascular disease
- •Have active or a history of pneumonitis or interstitial lung disease that requires corticosteroid treatment. Patients with radiation pneumonitis that does not require treatment is allowed.
- •Have uncontrolled diabetes.
- •Have received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.
- •Subjects known to be hypersensitive to bulumtatug fuvedotin or to any components of the formulation.
- •History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
- •Have received a live vaccine within 30 days of planned start of study therapy.
研究组 & 干预措施
Dose level 1 of BFv
Experimental
干预措施: bulumtatug fuvedotin (Drug)
Dose level 2 of BFv
Experimental
干预措施: bulumtatug fuvedotin (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to approximately 2 years
Objective Response Rate according to RECIST v1.1 by investigator assessment
次要结局
- Disease control rate(Up to approximately 2 years)
- Clinical benefit rate(Up to approximately 2 years)
- Duration of response(Up to approximately 2 years)
- Progression-free survival(Up to approximately 2 years)
- Overall survival(Up to approximately 2 years)
- Time to Maximum Concentration (Tmax)(Up to approximately 2 years)
- Maximum Concentration (Cmax)(Up to approximately 2 years)
- Half-life (t1/2)(Up to approximately 2 years)
- Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)(Up to approximately 2 years)
- Incidence, rate and severity of treatment-emergent adverse events.(Up to approximately 2 years)
- Immunogenicity(Up to approximately 2 years)
研究者
研究点 (10)
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