A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer

Официальное название

An Open-Label, Multi-Center Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant or Letrozole in Patients With Solid Tumor

Обзор

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.

Вмешательства

• Препарат HRS-6209 Capsules and fulvestrant injection
  HRS-6209, 100mg BID for 4 weeks, and single dose of fulvestrant injection

Первичные конечные точки

• Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs), [Срок оценки: Screening up to study completion,, an average of 1 year.]

Вторичные конечные точки (7)

• Concentration [Срок оценки: From administration to Cycle2 , up to 4 months.]
• Cmax,ss [Срок оценки: From administration to Cycle2, up to 4 months.]
• Cmin,ss [Срок оценки: From administration to Cycle2, up to 4 months.]
• Objective Response Rate (ORR) [Срок оценки: Screening up to study completion, an average of 2 years.]
• Best of Response (DoR) [Срок оценки: Screening up to study completion, an average of 2 years.]
• Disease Control Rate (DCR) [Срок оценки: Screening up to study completion, an average of 2 years.]
• rPFS (radiographic progression-free survival [Срок оценки: Screening up to study completion, an average of 2 years.]

Критерии участия

Критерии включения

• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
• Adequate bone marrow and other vital organ functions
• Adequate liver function tests
• HR-positive or HER2-negative solid tumor patients

Критерии исключения

• Plan to receive any other anti-tumor therapy during the study.
• Active brain metastases .
• Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure.
• Previous use of fulvestrant
• clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
• With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease).
• With acute or active tuberculosis infection requiring medication.
• Pregnant or lactating women, or females planning to become pregnant During the study.
• Known history of clinically significant liver disease, untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\] positive

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

Австралия · 3 центра

• Lyell McEwin Hospital — Elizabeth Vale
• Ballarat Base Hospital — Ballarat
• Frankston Hospital — Frankston

Идентификаторы

NCT: NCT07358377 · HRS-6209-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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