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Набор скоро начнётся NCT07113964

QL1706 With Olaparib for Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency (HRD)

Фаза II С лечением Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency

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: QL1706 + olaparib.
Кому может быть актуально
Состояния в реестре: Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency. Базовые параметры: 18 лет — 75 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
Китай
Следующий шаг
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Официальное название

QUEEN-OSCAR: A Prospective, Multicenter, Single-arm, Phase 2 Study of QL1706 in Combination With Olaparib in Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency (HRD)

Обзор

This study will evaluate the safety and efficacy of QL1706 and Olaparib in human epidermal growth factor receptor 2 (HER2)-negative unresectable and/or metastatic breast cancer who had received 2-4 line of prior systematic therapy.

Вмешательства

  • Препарат QL1706 + olaparib
    QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD1 IgG4 and anti-CTLA4 IgG1 antibodies. Other Names: Iparomlimab and Tuvonralimab Injection Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor with biologic activity in ovarian cancer as well as other solid tumors.. Other Names: NA

Первичные конечные точки

  • Progression-free Survival (PFS) [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

  • Age 18 - 75 years; Eastern Cooperative Oncology Group (ECOG) score status 0-1.
  • Pathologically documented HER2-negative locally advanced or metastatic breast cancer (IHC0, IHC 1+\& IHC 2+/ISH-) that was hormone-receptor positive (i.e., estrogen-receptor positive, progesterone-receptor positive, or both) or was triple negative.
  • Has been treated with 2-4 previous therapy regimens for metastatic disease.
  • HRD positive confirmed, known germline and/or systemic BRCA mutation status that is predicted to be deleterious or suspected deleterious allow preferential enrolment.
  • At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1.
  • Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
  • A life expectancy of at least 12 weeks.
  • Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 3 months. Negative serum or urine pregnancy test within 7 days before study enrollment, and must be a non-lactating subject.
  • Volunteer to participate in this study and sign the informed consent.

Критерии исключения

  • Has any active autoimmune disease, which may worsen when receiving immune stimulants.
  • Prior treatment with immune checkpoint inhibitors (ICI) (anti-CTLA-4, anti-PD-1, anti-PD-L1, combined therapy anti-PD-1/PD-L1 with anti-CTLA-4) or olaparib for advanced disease.
  • Has unresolved toxicities from previous anticancer therapy.
  • Has uncontrolled or significant cardiovascular disease.
  • Discontinuation of prior anti-PD-1/PD-L1/CTLA-4 therapy due to immune-related toxicity.
  • Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.
  • Has received a live vaccine vaccination within 28 days before enrolment.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has known history of or is positive for Hepatitis B or Hepatitis C.
  • Any severe or poorly controlled systemic disease such as poorly controlled hypertension, active bleeding susceptibility or active infection, as judged by the investigator.
  • Has untreated or clinically active central nervous system metastases.
  • Female subjects who are pregnant, lactating or plan to become pregnant during the study.
  • Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07113964 · QLMA-BC-IIT-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗