A Study of HRS-2329 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Официальное название

A Phase I Study of HRS-2329 Evaluating Safety, Tolerability, and Pharmacokinetics in Subjects With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Обзор

This is an open-label, multi-center phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of HRS-2329 in participants with advanced solid tumors harboring RAS mutations or amplifications.

Вмешательства

• Препарат HRS-2329 Tablet
  Oral HRS-2329 tablet.

Первичные конечные точки

• Incidence and severity of adverse events (AEs). [Срок оценки: From the screening period to 30 days after the last dose.]
• Incidence and severity of serious adverse events (SAEs). [Срок оценки: From the screening period to 30 days after the last dose.]
• Dose-limiting toxicity (DLT). [Срок оценки: From Day 1 to Day 21.]
• Maximum tolerated dose (MTD). [Срок оценки: From Day 1 to Day 21.]
• Recommended Phase II Dose (RP2D). [Срок оценки: 24 months.]

Вторичные конечные точки (12)

• Maximum plasma concentration (Cmax). [Срок оценки: About 24 months.]
• The time to maximum concentration (Tmax). [Срок оценки: About 24 months.]
• Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t). [Срок оценки: About 24 months.]
• Area under concentration-time curve from time 0 to infinity (AUC 0-∞). [Срок оценки: About 24 months.]
• Apparent volume of distribution (Vz/F). [Срок оценки: About 24 months.]
• Elimination half-life (t1/2). [Срок оценки: About 24 months.]
• Apparent clearance (CL/F). [Срок оценки: About 24 months.]
• Minimum concentration at steady state (Cmin, ss). [Срок оценки: About 24 months.]
• Area under the blood concentration-time curve at steady state (AUCss). [Срок оценки: About 24 months.]
• Accumulation ratio (Rac). [Срок оценки: About 24 months.]
• Objective response rate (ORR). [Срок оценки: About 24 months.]
• Duration of response (DoR). [Срок оценки: About 24 months.]

Критерии участия

Критерии включения

• Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;
• Aged between 18-75 years old;
• Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor RAS mutations or amplifications and have failed standard treatment;
• ECOG performance status (PS) score of 0 or 1;
• Life expectancy > 3 months;
• At least one measurable lesion per RECIST v1.1;
• Adequate organ function.

Критерии исключения

• Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/exclusion criteria;
• Presence of central nervous system (CNS) metastases;
• Participants with gastrointestinal diseases that affect drug administration/absorption;
• Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major surgery during the study period;
• Presence of serious pulmonary diseases;
• Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;
• Active or persistent gastrointestinal bleeding within 6 months prior to screening;
• History of allogeneic bone marrow or solid organ transplantation;
• History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
• Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);
• Known history of hypersensitivity to any component of the drug product to be used in the 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

• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07189949 · HRS-2329-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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