NCT05231746已完成1 期
A Phase 1, Multicenter, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of hSTC810 Monotherapy in Subjects With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- STCube, Inc.
- 入组人数
- 47
- 试验地点
- 9
- 主要终点
- Incidence of DLTs
研究概览
简要总结
The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.
详细描述
The study consists of a dose-escalation phase that will evaluate 6 dosing schedules of hSTC810. The first cohort will be single participant cohort. Subsequent escalation cohorts will use a standard 3+3 design, with the ability to backfill up to an additional 6 patients in each dose cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged at 18 ≥ years
- •Capable and willing to give signed informed consent
- •At least one measurable lesion as determined by RECIST Ver.1.1
- •ECOG PS score ≤ 1
- •Expected survival ≥ 12 weeks
- •For female or male patients of reproductive potential: Agree to use contraception throughout the study and at least 6 months after the last dose.
排除标准
- •Subject who has received anti-cancer treatment within 4 weeks prior to the first dose of study treatment.
- •Subject who has received radiotherapy or major surgery within 4 weeks prior to screening.
- •Any toxicity due to prior therapy that has not resolved to ≤ Grade 1 or returned to baseline by the time of starting study treatment.
- •Subject with known severe (≥Grade 3) hypersensitivity to any checkpoint inhibitor.
- •Clinically significant laboratory abnormalities.
- •Subject with a history of another invasive malignancy within 3 years before the first dose of study drug.
- •Subject with active central nervous system (CNS) metastases.
- •Subject who requires high dose of steroids or other immunosuppressive medications.
- •Subject with a history of autoimmune disease that has required systemic treatment in the past 2 years.
- •Subject with active infection that requires systemic antimicrobial treatment.
- •Subject with active HBV or HCV infection.
- •Subject who has a known history of HIV infection.
- •Subject with active tuberculosis.
- •Subject with a documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class IV within 6 months prior to screening.
- •Subject with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan.
- •Subject who has received a prior allogeneic stem cell or solid organ transplant.
- •Subject with a positive coronavirus disease (COVID) test during screening.
- •Subjects who have received a live attenuated vaccine within 30 days prior to screening.
- •Subject with another underlying medical condition.
结局指标
主要结局
Incidence of DLTs
时间窗: 4 weeks
Number and percentages of subjects with DLTs
Incidence of AEs, SAEs, and abnormalities in Lab
时间窗: from signing ICF to 90 days after last dose
Number and percentages of subjects with Adverse Event, serious AEs, and abnormalities in lab parameters
次要结局
- Progression free survival (PFS)(Up to 2 years)
- Minimum plasma concentration (Cmin)(Up to 2 years)
- Time to maximum plasma concentration (Tmax)(Up to 2 years)
- Peak plasma concentration (Cmax)(Up to 2 years)
- Incidence of ADA(Up to 2 years)
- Objective response rate (ORR)(Up to 2 years)
- Best overall response (BOR)(Up to 2 years)
- Clinical Benefit rate (CBR)(Up to 2 years)
- Area under the plasma concentration - time curve (AUC0-t)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Duration of response (DoR)(Up to 2 years)
研究者
研究点 (9)
Loading locations...
相似试验
进行中（未招募）
1 期
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)Advanced Solid TumorNCT06421935EMD Serono Research & Development Institute, Inc.60
已完成
1 期
Open Label Phase 1 Study in Japan for Patient With Advanced Solid MalignanciesAdvanced Solid MalignancyAdvanced Solid TumorNCT01353781AstraZeneca39
已完成
1 期
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal MelanomaUveal MelanomaChoroid NeoplasmNCT02771340Iconic Therapeutics, Inc.10
已完成
1 期
A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid TumorsAdvanced Solid TumorNCT05594875Atridia Pty Ltd.9
招募中
1 期
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) TherapyNon-Muscle-Invasive Bladder Cancer (NMIBC)NCT06351904Ractigen Therapeutics.72