Phase I Study of HRS-3005 in B-cell Malignancies

Официальное название

An Open-Label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-3005 in Patients With B-cell Malignancies

Обзор

The study is being conducted to evaluate the safety and tolerability of HRS-3005. To explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-3005 in patients with B-cell malignancy.

Вмешательства

• Препарат HRS-3005
  HRS-3005

Первичные конечные точки

• Safety Endpoints: Incidence of adverse events (AEs)，number of participants with abnormal laboratory test results . [Срок оценки: approximately 1 year]
• MTD（Maximum tolerated dose） [Срок оценки: 28 days after treatment initiation]
• RP2D（Recommended Phase II Dose） [Срок оценки: approximately 2 year.]

Вторичные конечные точки (11)

• Peak Concentration (Cmax) [Срок оценки: 12 weeks after treatment initiation]
• Time to Peak Concentration (Tmax) [Срок оценки: 12 weeks after treatment initiation;]
• Area Under the Curve (AUC0-t, AUC0-inf) [Срок оценки: 12 weeks after treatment initiation;]
• Half-life (t1/2) [Срок оценки: 12 weeks after treatment initiation;]
• Apparent Clearance (CL/F) [Срок оценки: 12 weeks after treatment initiation;]
• Apparent Volume of Distribution (Vz/F) [Срок оценки: 12 weeks after treatment initiation]
• Objective Response Rate (ORR) [Срок оценки: approximately 1 year;]
• Time to Response (TTR) [Срок оценки: approximately 1 year;]
• Duration of Response (DoR) [Срок оценки: approximately 1 year;]
• Progression-Free Survival (PFS) [Срок оценки: approximately 1 year;]
• Overall Survival (OS) [Срок оценки: approximately 1 year]

Критерии участия

Критерии включения

• Age ≥18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Life expectancy ≥12 weeks;
• Histologically or cytologically confirmed relapsed/refractory B-cell malignancies;
• Measurable disease;
• Adequate organ function;
• Females of childbearing potential must not be pregnant or lactating. Females of childbearing potential and males with partners of childbearing potential must agree to use effective contraception from the time of informed consent until 28 days after the last dose of study treatment;
• Voluntary participation with signed informed consent, good compliance, and willingness to complete follow-up visits.

Критерии исключения

• Known central nervous system (CNS) involvement by malignancy;
• History of other malignancy within 2 years prior to first dose of study drug, except for the disease under study;
• Prior autologous stem cell transplantation or CAR-T therapy within 12 weeks before first dose of study drug;
• Prior allogeneic hematopoietic stem cell transplantation;
• Positive hepatitis B surface antigen (HBsAg) with detectable HBV-DNA at screening;
• Positive hepatitis C antibody with detectable HCV-RNA at screening;
• Positive HIV antigen/antibody test at screening;
• Active fungal, bacterial, and/or viral infection requiring systemic therapy;
• Major surgery or significant trauma within 28 days prior to first dose of study drug;
• Severe disease of major organ systems;
• Prior anti-tumor treatment-related adverse events not recovered to ≤Grade 1 or stable status;
• Incomplete washout period from prior anti-tumor therapy before first dose of study drug;
• Use of strong or moderate CYP3A inducers, or strong or moderate CYP3A inhibitors within 14 days prior to first dose of study drug;
• Live vaccine administration within 28 days prior to first dose of study drug;
• Ongoing alcohol or drug abuse;
• Intracranial hemorrhage within 6 months prior to first dose of study drug;
• Currently receiving vitamin K antagonists or Factor Xa inhibitors;
• History of severe bleeding disorder, such as coagulation factor deficiency or von Willebrand factor (vWF) deficiency;
• Inability to swallow oral medication, or presence of severe gastrointestinal disease or prior surgery significantly affecting gastrointestinal function;
• Pregnant or lactating females;
• Concurrent participation in another interventional clinical study, or less than 1 month between signing informed consent and last dose of previous clinical study.

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 · 1 центр

• Hematology Hospital of the Chinese Academy of Medical Sciences — Тяньцзинь

Идентификаторы

NCT: NCT07556822 · HRS-3005-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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