NCT06094556招募中1 期
A Multicenter, Open Phase I Clinical Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-1826 for Injection in Patients 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
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
This is an open, multi-center, dose-escalation/dose-expansion/efficacy expansion phase I clinical study to evaluate the tolerability, safety, PK, and immunogenicity of SHR-1826 in patients with advanced malignant solid tumors, and to preliminatively observe its antitumor efficacy. The whole study was divided into three stages: dose increment, dose extension and therapeutic effect extension.
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
- •Able and willing to provide a written informed consent.
- •18-75 years old ，Male or female.
- •ECOG score is 0 or
- •Subjects with advanced or metastatic solid tumors that have been documented by histopathology and are not responding to or tolerated by standard treatment, or have no effective standard treatment options.
- •Have at least one measurable lesion according to RECIST v1.1 criteria.
- •Expected survival ≥3 months .
- •With good vital organ function.
- •Contraception.
排除标准
- •With untreated or active Central nervous system (CNS) tumor metastasis. Subjects with a history or current history of meningeal metastasis.
- •Previous or co-existing malignant tumors.
- •Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
- •Patients with uncontrolled tumor-related pain.
- •Received systemic antitumor therapy 4 weeks before starting study treatment; Previously receiving small molecule targeted therapy, the interval of not less than 5 half-lives of the drug can be enrolled.
- •Previously received antibody-coupled drug therapy.
- •Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing.
- •First study subjects receiving >30Gy non-radical chest radiation within 28 days prior to administration, >30Gy chest radiation within 24 weeks prior to first administration, and ≤30Gy palliative radiation within 14 days prior to first administration;If previously received radioisotope therapy, the interval of not less than 5 half-lives of the isotope drug can be included.
- •Is participating in another clinical study or the time of first administration is less than 4 weeks from the end of the previous clinical study (last administration), or the 5 half-life of the investigational drug, whichever is the older.
- •The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤
- •Other severe lung diseases that may interfere with the detection or management of drug-related pulmonary toxicity within the first three months of administration that significantly affect respiratory function; Any autoimmune, connective tissue, or inflammatory disease with lung involvement; Prior left or right total lung resection.
- •Pleural effusion, ascites, or pericardial effusion requiring intervention occurred within 2 weeks prior to the first dose.
- •Have an active autoimmune disease, or other acquired (HIV infection), congenital immunodeficiency disease, or a history of organ transplantation.
- •Have poorly controlled or severe cardiovascular disease.
- •Known hereditary or acquired bleeding and thrombotic tendencies, and clinically significant bleeding symptoms and arterial/venous thrombosis events in the 3 months prior to the first dose.
- •Untreated active hepatitis.
- •Subjects who had a severe infection within 30 days prior to the first dose; Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment were found by medical history or CT examination, or had a history of active pulmonary tuberculosis infection more than 1 year ago but had not received regular treatment.
- •Live attenuated vaccine should be administered within 30 days prior to the first dose.
- •Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- •Known allergy to any component or excipient of the SHR-1826 product.
- •The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participation in the study, or interfere with the study results, as well as conditions that the investigator deems inappropriate to participate in the study.
研究组 & 干预措施
SHR-1826
Experimental
Dose escalation; Dose expansion; Therapeutic effect expansion.
干预措施: SHR-1826 (Drug)
结局指标
主要结局
Dose-limiting toxicity
时间窗: 21 Days
evaluate the safety in the doses escalation
Maximum tolerated dose or Maximum-administered dose
时间窗: Approximately 1 year
evaluate the safety in the doses escalation
Recommended Phase 2 dose (RP2D)
时间窗: Approximately 2 years
evaluate the safety and curative effect in the doses escalation
次要结局
- Clearance rate (CL) of SHR-1826(Approximately 2 years)
- Anti-drug antibody of SHR-1826(Approximately 2 years)
- Maximum concentration (Cmax) of SHR-1826(Approximately 2 years)
- Duration of response (DoR)(Approximately 2 years)
- Disease control rate (DCR)(Approximately 2 years)
- Overall survival (OS)(Approximately 2 years)
- Time to maximum concentration (Tmax) of SHR-1826(Approximately 2 years)
- Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1826(Approximately 2 years)
- Areas under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of SHR-1826(Approximately 2 years)
- Mean retention times (MRT) of SHR-1826(Approximately 2 years)
- Half-life (t1/2) of SHR-1826(Approximately 2 years)
- Volume of distribution at the steady state (Vss) of SHR-1826(Approximately 2 years)
- Objective response rate (ORR)(Approximately 2 years)
- Progression free survival (PFS)(Approximately 2 years)
研究者
研究点 (1)
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