NCT07134998招募中1 期
A Phase I Study of HRS-6093 Evaluating Safety, Tolerability, and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events/serious adverse events (graded as per CTCAE v5.0).
研究概览
简要总结
This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.
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, with no gender requirement;
- •Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor KRAS G12D mutations; Have failed standard treatment, are intolerant to standard treatment, or have not received standard treatment.
- •ECOG performance status (PS) score of 0 or 1;
- •Life expectancy > 3 months;
- •At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided.
- •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-6093
Experimental
干预措施: HRS-6093 (Drug)
结局指标
主要结局
Incidence and severity of adverse events/serious adverse events (graded as per CTCAE v5.0).
时间窗: Screening Period to 30 Days After the Last Dose
DLT,
时间窗: from day1 to day 23; 23 Days
MTD,
时间窗: from day1 to day 23; 23 Days
RP2D ,
时间窗: 24 months
次要结局
- Number of Participants With Abnormal Laboratory Values(Screening Period to 30 Days After the Last Dose; 24 months)
- Number of subjects with clinically significant changes in ECOG, vital signs and physical examination.(Screening Period to 30 Days After the Last Dose; 24 months)
- Number of subjects with changes on ECG.(Screening Period to 30 Days After the Last Dose; 24 months)
- maximum plasma concentration (Cmax),(Screening Period to Day of the end of treatment/withdrawal. 24 months)
- time to maximum concentration (Tmax),(Screening Period to Day of the end of treatment/withdrawal. 24 months)
- area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t),(Screening Period to Day of the end of treatment/withdrawal. 24 months)
- Area under concentration-time curve from time 0 to infinity (AUC 0-∞), apparent volume of distribution (Vz/F),(Screening Period to Day of the end of treatment/withdrawal. 24 months)
- elimination half-life (t1/2), and apparent clearance (CL/F);(Screening Period to Day of the end of treatment/withdrawal. 24 months)
- minimum concentration at steady state (Cmin, ss),(Screening Period to Day of the end of treatment/withdrawal. 24 months)
- area under the blood concentration-time curve at steady state (AUCss), and accumulation ratio (Rac);(Screening Period to Day of the end of treatment/withdrawal. 24 months)
- objective response rate (ORR),(Screening Period to PD; 24 months)
- duration of response (DoR),(Screening Period to PD; 24 months)
- disease control rate (DCR),(Screening Period to PD; 24 months)
- progression-free survival (PFS),(Screening Period to PD; 24 months)
- overall survival (OS).(Screening Period to Day of death of the participant;24months)
研究者
研究点 (2)
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