A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs

Официальное название

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

Обзор

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.

Вмешательства

• Препарат bulumtatug fuvedotin
  given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
• Препарат bulumtatug fuvedotin
  given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2

Первичные конечные точки

• Objective Response Rate [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (12)

• Disease control rate [Срок оценки: Up to approximately 2 years]
• Clinical benefit rate [Срок оценки: Up to approximately 2 years]
• Duration of response [Срок оценки: Up to approximately 2 years]
• Progression-free survival [Срок оценки: Up to approximately 2 years]
• Overall survival [Срок оценки: Up to approximately 2 years]
• Time to Maximum Concentration (Tmax) [Срок оценки: Up to approximately 2 years]
• Maximum Concentration (Cmax) [Срок оценки: Up to approximately 2 years]
• Half-life (t1/2) [Срок оценки: Up to approximately 2 years]
• Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) [Срок оценки: Up to approximately 2 years]
• Incidence, rate and severity of treatment-emergent adverse events. [Срок оценки: Up to approximately 2 years]
• Immunogenicity [Срок оценки: Up to approximately 2 years]
• Immunogenicity [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• 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.
• ECOG 0-1
• Adequate hematologic and organ function
• Life expectancy of at least 3 months as assessed by the investigator
• Compliance with contraceptive requirement

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• City of Hope — Duarte
• UCSD Moores Cancer Center — La Jolla
• Anschutz Medical Center — Aurora
• UChicago Medicine Comprehensive Cancer Center — Chicago
• Massachusetts General Hospital — Boston
• Memorial Sloan Kettering Cancer Center — New York

Идентификаторы

NCT: NCT06908928 · 9MW2821-2022-CP103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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