NCT06487455招募中1 期
An Open, Multicenter, Dose-escalation, and Dose-expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SPH7485 Tablets in Patients With Advanced Solid Tumors.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 6
- 主要终点
- Maximum tolerated dose（MTD）
研究概览
简要总结
To evaluate the efficacy and safety of SPH7485 tablets 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
- •Histologically or cytologically confirmed advanced solid tumors；
- •At least one extracranial measurable lesion;
- •ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
- •Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;
- •Life expectancy≥3 months;
- •Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1;
- •Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception;
- •Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures.
排除标准
- •Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;
- •Subjects who have received previous drugs with the same target;
- •Subjects with active infections requiring systemic treatment;
- •Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;
- •Subjects with uncontrolled or severe cardiovascular disease;
- •Severe lung disease;
- •Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug;
- •Subjects taking strong/moderate inhibitors or inducers of CYP3A4;
- •Subjects who use or require long-term use of hormonotherapy before screening;
- •Subjects who have had other malignancies within the past 5 years;
- •Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis;
- •Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery;
- •Abnormal virological examination during screening; History of immune deficiency;
- •Uncontrolled systemic diseases;
- •Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose;
- •Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose;
- •Subjects with a history of severe allergy or known allergy to this product and its excipients;
- •Subjects who cannot follow the study protocol to complete the required study visit and dosing;
- •Subjects with a history of alcohol or drug abuse;
- •Lactating female patients;
- •Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator;
- •Subjects deemed unsuitable for this clinical study by the investigator for other reasons.
研究组 & 干预措施
SPH7485
Experimental
干预措施: SPH7485 (Drug)
结局指标
主要结局
Maximum tolerated dose（MTD）
时间窗: Approximately 24 days
Measurement of MTD of SPH7485 in all subjects
DLT(Dose-limiting toxicity)
时间窗: Approximately 24 days
Measurement of DLT of SPH7485 in all subjects
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
次要结局
- ORR(Objective Response Rate)(Approximately 2 years)
- DCR(Disease Control Rate)(Approximately 2 years)
- PK(Pharmacokinetics):Cmax(Approximately 3 days)
- DoR(Duration of response)(Approximately 2 years)
- PK(Pharmacokinetics):Tmax(Approximately 3 days)
- PK(Pharmacokinetics):AUC(Approximately 3 days)
- PFS(Progression-free survival)(Approximately 2 years)
研究者
研究点 (6)
Loading locations...
相似试验
终止
1 期
Dose-escalation Study of Birinapant and Pembrolizumab in Solid TumorsSolid TumorsNCT02587962Medivir34
招募中
早期 1 期
A Clinical Study of SPH7854 Granules in Healthy Subjects.Inflammatory Bowel DiseaseNCT06483373Shanghai Pharmaceuticals Holding Co., Ltd111
已完成
1 期
A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast CancerHER2-negative Metastatic Breast CancerNCT05261269Dantari, Inc.30
终止
1 期
Dose Escalation Study of SH U04722 in Solid TumorsTumorsNCT00375453Bayer10
终止
1 期
A Study of HRS2543 in Patients With Advanced TumorsAdvanced TumorsNCT05068856Shanghai Hengrui Pharmaceutical Co., Ltd.10