A Trial of HRS-6768 in Patients With Advanced Solid Tumors

Официальное название

A Phase I/II Clinical Trial to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-6768 in the Treatment of Patients With Advanced Solid Tumors

Обзор

The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of patients with advanced solid tumors.

Вмешательства

• Препарат HRS-6768
  HRS-6768

Первичные конечные точки

• Phase 1:Dose-limiting toxicity (DLTs) [Срок оценки: From first dose of study drug through at least 6 weeks]
• Phase 1: recommended Phase 2 dose (RP2D) [Срок оценки: From first dose of study drug to end of phase 1 treatment (up to approximately 1 years)]
• Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768 [Срок оценки: From first dose of study drug to end of treatment (up to approximately 2 years)]
• Phase 2: Progression-free survival (PFS) [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]

Вторичные конечные точки (10)

• Phase 1/2: Absorbed dose (Gy) estimated in organs and tumor lesions [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]
• Phase 1/2: Cmax of HRS-6768 [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]
• Phase 1/2: Tmax of HRS-6768 [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]
• Phase 1/2: Area under the curve (AUC) of HRS-6768 [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]
• Phase 1/2: clearance (CL) of HRS-6768 [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]
• Phase 1/2: Objective Response Rate (ORR) [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 1 years)]
• Phase 1/2: Duration of Response (DoR) [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]
• Phase 1/2: Disease Control Rate (DCR) [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]
• Phase 1: Progression-free survival (PFS) [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]
• Phase 1/2: Overall Survival (OS) [Срок оценки: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)]

Критерии участия

Критерии включения

• Able and willing to provide a written informed consent
• subjects with solid tumors who have been histologically or cytologically diagnosed with advanced - stage (unresectable or metastatic) disease, have failed standard treatment (disease progression or intolerance), or lack effective treatment methods.
• There must be at least one evaluable lesion .
• ECOG 0-1
• The functions of major organs are in good condition.

Критерии исключения

• The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
• The patient has previously received radiopharmaceutical therapy or radioactive embolization, or has previously undergone any external beam radiotherapy (EBRT) involving more than 25% of the bone marrow, or has previously had EBRT directly applied to the kidneys, or has received any EBRT within 2 weeks before the first dose.
• The patient has received anti - tumor treatments such as surgery (excluding diagnostic biopsy and serous cavity effusion drainage), checkpoint inhibitor therapy, other antibody therapies, chemotherapy, targeted therapy, gene therapy, and vaccine therapy within 4 weeks before the first dose.
• The patient has had a severe infection (CTCAE > Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. The patient has had symptoms and signs of infection within 2 weeks before the first dose that require intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use).

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 · 2 центра

• Beijing Gaobo Hospital — Пекин
• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06925581 · HRS-6768-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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