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Идёт набор NCT06315491

A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

Фаза II С лечением Platinum-resistant Ovarian Cancer Refractory Ovarian Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CBX-12.
Кому может быть актуально
Состояния в реестре: Platinum-resistant Ovarian Cancer, Refractory Ovarian Carcinoma. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

Обзор

The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days.

Вмешательства

  • Препарат CBX-12
    CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.

Первичные конечные точки

  • Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] [Срок оценки: Randomization to progressive disease (PD) (Up to approximately 21 months)]
Вторичные конечные точки (11)
  • Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)]
  • Median Duration of Response (DoR) [Срок оценки: Date of Initial CR or PR to PD (Up to 21 Months)]
  • Progression-Free Survival (PFS) [Срок оценки: Randomization to PD or Date of Death (Up to 21 Months)]
  • Plasma levels of CBX-12 (AUC0-24hr) [Срок оценки: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose]
  • Plasma levels of CBX-12 (Cmax) [Срок оценки: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose]
  • Plasma levels of CBX-12 (Tmax) [Срок оценки: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose]
  • Plasma levels of CBX-12 (T1/2) [Срок оценки: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose]
  • Plasma levels of Exatecan (AUC0-24hr) [Срок оценки: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose]
  • Plasma levels of Exatecan (Cmax) [Срок оценки: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose]
  • Plasma levels of Exatecan (Tmax) [Срок оценки: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose]
  • Plasma levels of Exatecan (T1/2) [Срок оценки: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose]

Критерии участия

Критерии включения

  • Subjects must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that is refractory to prior therapy and must have platinum-resistant disease defined as:
  • Subjects who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or occurring ≤ 26 weeks after their last dose of platinum.
  • Patients who have progressed following a second course of a platinum based regimen.
  • Subjects may have up to 2 additional systemic regimens for advanced or metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or bevacizumab) are not considered separate regimens.
  • Age greater than or equal to 18 years at the time of signing the informed consent form (ICF).
  • Has measurable disease per RECIST 1.1.
  • Has provided written informed consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate liver, renal, hematologic, pulmonary and coagulation function.

Критерии исключения

  • Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12.
  • Subjects who are currently receiving any other anticancer or investigational agent(s).
  • Clinically significant intercurrent disease.
  • Active human immunodeficiency virus (HIV) infection.
  • Active hepatitis B or C infection.

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 · 17 центров
  • Honor Health — Scottsdale
  • Arizona Oncology Associates — Tucson
  • Usc Norris Comprehensive Cancer Center — Los Angeles
  • Yale University School of Medicine — New Haven
  • D&H Cancer Research Center — Margate
  • South Florida Gynecology — Tampa
  • Northwest Cancer Centers — Dyer
  • Norton Cancer Institute — Louisville
  • … и ещё 9 центров

Идентификаторы

NCT: NCT06315491 · CBX-12-201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗