NCT03475251已完成1 期
A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
- •ECOG performance status of 0 or
- •Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
- •Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
- •Life expectancy ≥ 3 months.
- •Subject must have adequate organ function.
- •Use of effective contraception (males and females).
排除标准
- •Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
- •Subjects with active autoimmune diseases or history of autoimmune diseases.
- •Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS
- •Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib, except for those with basal cell carcinoma, in situ breast cancer and cervical carcinoma in situ who have undergone radical treatment.
- •Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
- •Receipt of chemotherapy, targeted therapy, or any other anti-cancer systemic treatment within 2 weeks prior to the first dose of CS
- •Receipt of major surgical procedure or wide field of radiation within 28 days prior to the first dose of CS1003, local radiotherapy within 14 days prior to the first dose of CS1003, or radioactive agents within 56 days before the first dose of CS
- •Receipt of Chinese herbal medicine or Chinese prepared medicine within 7 days prior to the first dose of CS
- •Receipt of live vaccine within 28 days prior to the first dose of CS
- •History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
- •History of HIV infection.
- •Subjects with active Hepatitis B and C infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring therapy.
- •Subjects with active infection of tuberculosis.
- •Subjects with signs or symptoms of any active infection requiring systemic therapy.
- •History of organ transplantation.
- •Unresolved toxicities from prior anti-cancer therapy.
- •History of any irAE of Grade ≥
- •History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
- •History of alcoholism or drugs abuse.
- •Subjects with major cardiovascular diseases.
- •Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.
- •For more information regarding trial participation, please contact at cstonera@cstonepharma.com
研究组 & 干预措施
CS1003
Experimental
干预措施: CS1003 (Biological)
CS1003 + regorafenib
Experimental
干预措施: CS1003 (Biological)
CS1003 + regorafenib
Experimental
干预措施: Regorafenib (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: From the day of first dose to 30 days after last dose of CS1003
次要结局
- Area under the plasma concentration-time curve (AUC)(From the day of first dose to 30 days after last dose of CS1003)
- Time to reach maximum plasma concentration (Tmax)(From the day of first dose to 30 days after last dose of CS1003)
- Anti-CS1003 antibody(From the day of first dose to 30 days after last dose of CS1003)
- Maximum plasma concentration (Cmax)(From the day of first dose to 30 days after last dose of CS1003)
- Terminal elimination half-life (t1/2)(From the day of first dose to 30 days after last dose of CS1003)
- Disease assessment by CT/MRI scan(To be performed every 9 weeks during treatment period (up to 2 years) and within 30 days after last dose of CS1003)
研究者
研究点 (1)
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