A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors

Официальное название

A PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC CHARACTERISTICS, AND PRELIMINARY ANTI-TUMOR EFFICACY OF HEMAY5087 IN PATIENTS WITH ADVANCED SOLID TUMORS

Обзор

An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.

Вмешательства

• Препарат Hemay5087
  intravenous infusion，once every 3 weeks

Первичные конечные точки

• Number of participants with adverse events [Срок оценки: 3 weeks of treatment]
• Incidence of dose-limiting toxicity (DLT) in each dose group [Срок оценки: 3 weeks of treatment]
• Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181 [Срок оценки: 3 weeks of treatment]
• Subsequent recommended doses of Hemay181 [Срок оценки: 3 weeks of treatment]

Вторичные конечные точки (12)

• Objective Response Rate [Срок оценки: 3 weeks of treatment]
• Duration of Response [Срок оценки: 3 weeks of treatment]
• Disease Control Rate [Срок оценки: 3 weeks of treatment]
• Time to Response [Срок оценки: 3 weeks of treatment]
• Progression-Free Survival [Срок оценки: 3 weeks of treatment]
• Maximum Plasma Concentration （Cmax） [Срок оценки: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
• Time to reach maximum concentration （Tmax） [Срок оценки: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
• Elimination half life(t1/2) [Срок оценки: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
• Plasma Clearance（CL) [Срок оценки: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
• Mean Residence Time from 0 to last time of quantifiable concentration(MRT 0-t) [Срок оценки: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
• Mean Residence Time from 0 to infinite time(MRT 0-∞) [Срок оценки: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
• Area under the plasma concentration-time curve from 0 to last time of quantifiable concentration(AUC 0-t) [Срок оценки: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]

Критерии участия

Критерии включения

• Subjects who voluntarily signed a written informed consent form before the start of the study;
• Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .
• Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1;
• At least 4 weeks or 5 half-lives (whichever is shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] v6.0) \[except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk\];
• Subjects with ECOG PS score of 0-1;
• Subjects with expected survival more than 3 months;
• Participants (including their partners) have no plan for pregnancy from signing the informed consent form through 6 months after the last dose and voluntarily agree to use effective contraception;

Критерии исключения

• Women during pregnancy or breastfeeding;
• Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA > ULN;;
• Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;
• Aallergy to the active ingredient or excipients of the investigational medicinal product;
• Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;
• The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07624864 · HM5087ST1S01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗