A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

Официальное название

An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

Обзор

The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.

Вмешательства

• Препарат HRS-4508+ Capecitabine
  HRS-4508+ Capecitabine
• Препарат HRS-4508+ Trastuzumab
  HRS-4508+ Trastuzumab
• Препарат HRS-4508+ Trastuzumab+ Pertuzumab
  HRS-4508+ Trastuzumab+ Pertuzumab
• Препарат HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel
  HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel
• Препарат HRS-4508+ Trastuzumab + Nab-paclitaxel
  HRS-4508+ Trastuzumab + Nab-paclitaxel
• Препарат HRS-4508+ Trastuzumab+ Capecitabine
  HRS-4508+ Trastuzumab+ Capecitabine
• Препарат Trastuzumab+ Capecitabine
  Trastuzumab+ Capecitabine
• Препарат Trastuzumab+ Pertuzumab
  Trastuzumab+ Pertuzumab
• Препарат HRS-4508+SHR-A1811
  HRS-4508+SHR-A1811

Первичные конечные точки

• HRS4508 DLT [Срок оценки: 3 weeks]
• HRS4508 MTD [Срок оценки: 12 weeks]
• HRS4508 RP2D [Срок оценки: 12 weeks]
• The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) [Срок оценки: 2 years]
• Objective response rate (ORR) [Срок оценки: 1 year]

Вторичные конечные точки (11)

• Blood concentrations of HRS-4508 [Срок оценки: 15 weeks]
• Blood concentrations of SHR-A1811 [Срок оценки: 9 weeks]
• Blood concentrations of Capecitabine [Срок оценки: 2 weeks]
• Objective response rate (ORR) [Срок оценки: 1 year]
• Best overall efficacy (BOR) [Срок оценки: 1 year]
• Duration of response (DoR) [Срок оценки: 1 year]
• Progression free survival (PFS) [Срок оценки: 1 year]
• Disease control rate (DCR) [Срок оценки: 1 year]
• Overall survival (OS) [Срок оценки: 2 year]
• The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) [Срок оценки: 2 years]
• Blood concentrations of Paclitaxel for Injection [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Age: 18 to 75 years old; Both men and women are welcome;
• The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .
• ECOG ratings of 0 or 1.
• Expected survival period ≥ 12 weeks.
• At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
• Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.

Критерии исключения

• Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
• There have been significant severe infections and major surgeries in the past 4 weeks
• Existence of previous or concurrent malignant tumors
• Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
• Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital Chinese Academy of Medical Science — Пекин

Идентификаторы

NCT: NCT07140393 · HRS-4508-202-BC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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