NCT07189949招募中1 期
A Phase I Study of HRS-2329 Evaluating Safety, Tolerability, and Pharmacokinetics in Subjects With Advanced Solid Tumors Harboring RAS Mutations or Amplifications
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HRS-2329 Group
Experimental
干预措施: HRS-2329 Tablet (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs).
时间窗: From the screening period to 30 days after the last dose.
Graded as per CTCAE v5.0.
Dose-limiting toxicity (DLT).
时间窗: From Day 1 to Day 21.
Maximum tolerated dose (MTD).
时间窗: From Day 1 to Day 21.
Recommended Phase II Dose (RP2D).
时间窗: 24 months.
Incidence and severity of serious adverse events (SAEs).
时间窗: From the screening period to 30 days after the last dose.
Graded as per CTCAE v5.0.
次要结局
- Maximum plasma concentration (Cmax).(About 24 months.)
- Apparent volume of distribution (Vz/F).(About 24 months.)
- The time to maximum concentration (Tmax).(About 24 months.)
- Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t).(About 24 months.)
- Area under concentration-time curve from time 0 to infinity (AUC 0-∞).(About 24 months.)
- Elimination half-life (t1/2).(About 24 months.)
- Apparent clearance (CL/F).(About 24 months.)
- Minimum concentration at steady state (Cmin, ss).(About 24 months.)
- Area under the blood concentration-time curve at steady state (AUCss).(About 24 months.)
- Accumulation ratio (Rac).(About 24 months.)
- Objective response rate (ORR).(About 24 months.)
- Duration of response (DoR).(About 24 months.)
- Disease control rate (DCR).(About 24 months.)
- Progression-free survival (PFS).(About 24 months.)
- Overall survival (OS).(About 24 months.)
研究者
研究点 (1)
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