NCT04843033Unknown1 期
A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3809 Tablet in Patients With Advanced Solid Tumors in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose(MTD)
研究概览
简要总结
The primary objective is to determine the safety and tolerability of SH3809 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3809 in solid tumors.
详细描述
This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3809 tablet, a small molecule inhibitor of SHP2 receptor , in patients with advanced solid tumors.
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
- •Age between 18 and 75 years inclusive;
- •Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients should be either refractory or intolerant to all available therapies known to confer a clinical benefit as determined by the investigator, except for primary hepatic carcinoma;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Life expectancy ≥ 3 months;
- •Adequate hematologic, hepatic and renal function;
- •Participant willing to agree to not father a child/become pregnant and comply with effective contraception criteria;
- •Provision of signed and dated, written informed consent prior to any study-specific evaluation.
排除标准
- •Previous treatment with any SHP2 inhibitors;
- •Spinal cord compression, meningeal metastases or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment;
- •Life-threatening autoimmune disease or autoimmune disorder with long-term steroid treatment;
- •Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and treponema pallidum (TP);
- •Patients who have impaired cardiac function or clinically significant cardiac diseases;
- •Active, clinically significant interstitial lung disease or pneumonitis;
- •Females who are pregnant or breastfeeding;
- •Judgment by the investigator that the patient should not participate in the study.
研究组 & 干预措施
Daily oral administration of SH3809 tablet
Experimental
干预措施: SH3809 tablet (Drug)
结局指标
主要结局
Maximum tolerated dose(MTD)
时间窗: Within the first 28 days of consecutive treatment
Number of participants with dose limiting toxicities (DLTs)
时间窗: Within the first 28 days of consecutive treatment
Incidence and nature of DLTs in the dose escalation phase
次要结局
- Tmax(4 weeks])
- Progression-free survival(PFS)(up to 12 months)
- Disease control rates(DCR)(up to 12 months)
- Overall Response Rate(ORR)(up to 12 months)
- Duration of response(DOR)(up to 12 months)
- T1/2(4 weeks)
- Area Under the Curve (AUC)(4 weeks)
- Cmax(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
A Study to Investigate Safety and Tolerability of SH3765 Tablet in Patients With Advanced Malignant TumorAdvanced Malignant TumorNCT05015309Nanjing Sanhome Pharmaceutical, Co., Ltd.40
Unknown
1 期
A Study to Investigate Safety and Tolerability of SH3051 Capsule in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT04423380Nanjing Sanhome Pharmaceutical, Co., Ltd.45
已完成
1 期
Phase 1 Dose Escalation Study of BAY 1841788 in Japanese Metastatic Castration-resistant Prostate Cancer (mCRPC) SubjectsProstatic NeoplasmsNCT02363855Bayer9
Unknown
1 期
A Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction PatientsErectile DysfunctionNCT03102398Tritech Biopharmaceuticals Co., Ltd.26
已完成
1 期
Selumetinib Paediatric NF1 Japan StudyNeurofibromatosis Type 1NCT04495127AstraZeneca12