jRCT2031240560招募中不适用
A Phase 1, open-label, multicenter clinical trial of S095035 (MAT2A inhibitor) in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP (S095035 in adult participants with advanced or metastatic solid tumors with deletion of MTAP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 主要终点
- Dose-limiting toxicities(DLTs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Males aged 18 years or older, or non-pregnant and non-lactating females.
- •ECOG PS: 0-
- •Patients with histologically confirmed advanced/metastatic solid tumors who have shown progression after prior treatment regimens and are considered unsuitable for standard therapies.
- •Participants with pre-existing documented MTAP homozygous deletion in their tumor tissue
- •Patients able to provide newly obtained tumor biopsy samples before Cycle1Day1 and during treatment.
- •Patients with adequate hematologic, renal, and hepatic function based on assessments within 7 days prior to the first dose of the investigational drug.
排除标准
- •Patients unable to take oral medication or with medical conditions or surgical history that may affect drug absorption.
- •Patients participating in another interventional study or within less than 5 half-lives of another investigational drug. (Participation in non-interventional registries or epidemiological studies is allowed.)
- •Patients with active secondary cancer (except for specific non-invasive cancers).
- •Patients who have undergone major surgery within 4 weeks prior to the first dose of the investigational drug or have not recovered from the side effects of surgery.
- •Patients with severe or uncontrolled active acute or chronic infections.
- •Patients with active brain metastases (symptomatic brain metastases or leptomeningeal disease).
- •Participants who have received systemic anticancer treatment or radiotherapy less than 2 weeks before the first dose of S
- •Patients with medical conditions that exacerbate clinically significant photosensitivity (e.g., solar urticaria, lupus erythematosus).
结局指标
主要结局
Dose-limiting toxicities(DLTs)
时间窗: first cycle of treatment
Dose-limiting toxicities(DLTs) associated with S095035 administration during the first cycle of treatment
Adverse events(AEs) and serious adverse events
Adverse events(AEs) and serious adverse events
Changes in safety laboratory results
Changes in safety laboratory results
Changes in the physical examination
Changes in the physical examination
Changes in vital signs
Changes in vital signs
Changes in electrocardiogram(ECG)
Changes in electrocardiogram(ECG)
Changes in Eastern Cooperative Oncology Group(ECOG) performance status(PS)
Changes in Eastern Cooperative Oncology Group(ECOG) performance status(PS)
次要结局
- AUC0-t
- AUC from time zero to infinity
- AUCtau,ss
- Tmax
- Cmax
- Ctrough
- t half
- Vd/F
- CL/F
- Changes from baseline in plasma concentrations of S-adenosylmethionine (SAM) and other PD biomarker candidates
- Objective response rate (ORR)
- Clinical benefit rate (CBR)
- Duration of response (DoR)
- Time to response (TTR)
研究者
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