An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer

Официальное название

An Open, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-7058 in Patients With Locally Advanced or Metastatic Pancreatic Cancer Harboring KRAS G12C Mutations Who Have Failed Prior Systemic Therapy.

Обзор

This is a multicenter, open-label, single-arm, phase II cilinical trial designed to evaluate the efficacy and safety of the KRAS G12C selective inhibitor HRS-7058 in patients with KRAS G12C-mutated advanced pancreatic cancer who had failed 1-2 lines of previous systemic therapy.

Вмешательства

• Препарат HRS-7058
  HRS-7058

Первичные конечные точки

• ORR as assessed by IRC [Срок оценки: About 2 years]

Вторичные конечные точки (5)

• Investigator-assessed ORR [Срок оценки: About 2 years]
• IRC and investigator-assessed DoR [Срок оценки: About 2 years]
• IRC and investigator-assessed DCR [Срок оценки: About 2 years]
• IRC and investigator-assessed PFS [Срок оценки: About 2 years]
• OS [Срок оценки: About 4 years]

Критерии участия

Критерии включения

• Informed consent was obtained from all participants before participating in the study.
• Age from 18 to 75 years old (including both ends), regardless of gender;
• Patients with locally advanced unresectable, recurrent unresectable or metastatic pancreatic cancer, and adenocarcinoma confirmed by cytology or histological pathology;
• Participants had received at least one previous systemic therapy
• At least one measurable lesion according to RECIST v1.1;
• ECOG PS score 0 or 1;
• The expected survival time was more than 3 months.
• They were able to swallow medications and were able to adhere to trial and follow-up procedures.
• Adequate bone marrow and organ function within 7 days before the first dose (no use of blood components and/or cell growth factors within 14 days before starting study treatment;
• Women of childbearing potential had to agree to abstain from sexual intercourse (heterosexual intercourse) or to use a highly effective method of contraception from the time they provided informed consent until 30 days after the last dose of the trial drug. A blood test for human chorionic gonadotropin (HCG) had to be negative within 7 days before starting study treatment and she had to be nonlactating (if a serum pregnancy test was positive, pregnancy was ruled out and enrollment was confirmed after discussion with the sponsor). Men whose partner was a woman of childbearing potential had to agree to abstain from sex or to use a highly effective method of contraception from the time they provided written informed consent until 30 days after the last dose of the trial drug. Male patients also had to agree not to donate sperm during the same period

Критерии исключения

• Presence of untreated or active central nervous system (CNS) metastases. Participants with a history of leptomeningeal metastasis or current leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis, and/or spinal cord compression.
• Subjects who had received general anesthesia
• Subjects with a history of myocardial infarction or unstable angina pectoris
• Subjects with atrioventricular block or cardiac insufficiency
• Subjects with a history of ischemic stroke or transient ischemic attack
• Subjects with poor blood pressure control after medication
• Subjects with abnormal clotting function
• Subjects with a history of mental illness and a history of cognitive impairment epilepsy
• Subjects with a history or possibility of a difficult airway
• Subject with a history of substance abuse and drug abuse
• Adrenoceptor agonists or antagonists were used before randomization
• Abnormal values in the laboratory
• Thyroid dysfunction
• Allergic to a drug ingredient or component
• Pregnant or nursing women
• No birth control during the specified period of time
• Participated in clinical trials of other drugs (received experimental drugs)
• The inestigators determined that other conditions were inappropriate for participation in this clinical trial

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

• Jiangsu Province Hospital — Нанкин
• Tianjin Medical University Cancer Institute & Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07589569 · HRS-7058-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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