NCT05198817Unknown1 期
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection or in Combination With Other Anti-cancer Therapy in Advanced Malignant Tumors of Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients. To explore the reasonable dosage of SHR-2002 injection monotherapy and dosage regimen of combination therapy for advanced malignant tumors of patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- •Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
- •Histopathologically or cytologically documented advanced or metastatic malignancies;
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- •Life expectancy ≥12 weeks;
- •Adequate organ functions as defined;
- •Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration; Female of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding.
排除标准
- •Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- •Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
- •Patients with tumor-related pain that cannot be controlled as determined by the investigator;
- •Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- •Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
- •Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment;
- •Patients who have received >30 Gy of radical radiotherapy within 28 days before the first dose of study treatment;
- •Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy;
- •Use of live attenuated vaccines within 28 days before the first dose of the study treatment;
- •Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment;
- •Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
- •History of autoimmune diseases;
- •History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment;
- •History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment;
- •Evidence or history of arterial/venous thrombosis within 3 months before the first dose;
- •Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
- •Known history of serious allergic reactions to the investigational product or its main ingredients;
- •History of immunodeficiency;
- •Presence of active hepatitis B or active hepatitis C;
- •Severe infections within 4 weeks prior to the first study treatment;
- •Evidence or history of active pulmonary tuberculosis within 1 year before study entry;
- •any other conditions that are not suitable for participation in the study in the investigator's opinion.
研究组 & 干预措施
Single Group
Experimental
干预措施: SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: first dose of study medication up to 21 days
The Maximum tolerated dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
Recommended phase II dose
时间窗: first dose of study medication up to 21 days
The Recommended phase II dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
时间窗: from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
次要结局
- Cytokine concentration(0.5 hour before second dose to the 30 days after last dose)
- Tmax(0.5 hour before first dose to the 336 hours after first dose)
- Cmax(0.5 hour before first dose to the 336 hours after first dose)
- AUC0-t(0.5 hour before first dose to the 336 hours after first dose)
- AUC0-∞(0.5 hour before first dose to the 336 hours after first dose)
- t1/2(0.5 hour before first dose to the 336 hours after first dose)
- CL(0.5 hour before first dose to the 336 hours after first dose)
- Vss(0.5 hour before first dose to the 336 hours after first dose)
- Cmax, ss(0.5 hour before second dose to the 30 days after last dose)
- Ctrough, ss(0.5 hour before second dose to the 90 days after last dose)
- Rac(0.5 hour before second dose to the 90 days after last dose)
- RO(0.5 hour before second dose to the 30 days after last dose)
- ADA(0.5 hour before second dose to the 90 days after last dose)
- NAb(0.5 hour before second dose to the 90 days after last dose)
- ORR(from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months])
- DCR(from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months)
- PFS(from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months)
- DoR(from the date of the firstly documented tumor response to the date of the firstly documented disease progression or the date of death for any reason, assessed up to 6 months)
- OS(from the date of the first dose to the date of death for any reason，assessed up to 100 months)
研究者
研究点 (5)
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