NCT05214976Enrolling By Invitation2 期
A Phase Ⅰb/Ⅱ Clinical Study on the Open-label and Multiple Centers of Camrelizumab for Injection in Combination With Famitinib Malate Capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Dose Limited Toxicity
研究概览
简要总结
The study is being conducted to evaluate safety, tolerability and preliminary efficacy of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) for advanced solid tumors of patients. To explore the reasonable dosage of 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
- •Dose Escalation Period: Histopathologically documented incurable advanced malignancies with standard treatment failure;
- •At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors;
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- •Life expectancy ≥3 months;
- •Adequate organ functions as defined;
- •Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.
排除标准
- •The imaging examinations shows the tumor invades large blood vessels; Or as the assessment of the investigator, the tumor is highly likely to invade important blood vessels which would cause fatal bleeding during treatment;
- •The imaging examinations shows significant pulmonary cavitary tumors occurs with the bleeding risk as the investigator's assessment;
- •patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, or spinal cord compression;
- •Uncontrollable pleural effusion, pericardial effusion or peritoneal effusion, with clinical symptoms;
- •Severe bong injury caused by metastatic tumor of bone;
- •Prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment;
- •History of autoimmune diseases;
- •Evidence or history of arterial/venous thrombosis within 6 months before the first dose;
- •Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
- •When receiving immune checkpoint inhibitors previously, myocarditis related with immune, ≥ grade 2 of pneumonia related with immune or ≥ grade 3 of other adverse reactions related with immune occurred.
研究组 & 干预措施
Single Group
Experimental
干预措施: Camrelizumab for Injection, Famitinib malate capsule, Paclitaxel For Injection(Albumin Bound) (Drug)
结局指标
主要结局
Dose Limited Toxicity
时间窗: first dose of study medication up to 21 days]
Dose Limited Toxicity of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound)
Recommended phase II dose
时间窗: first dose of study medication up to 21 days
The Recommended phase II dose of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound)
ORR
时间窗: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months
Objective Response Rate, Efficacy endpoints of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients
次要结局
- DoR(from the date of the firstly documented tumor response (evaluated based on RECIST v1.1 criteria) to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, 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, 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, up to 6 months)
- The occurrence rate of dose titration(from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months)
- concentration of drug in plasma(2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule)
- CL/F(2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule)
- NAb(the date of first dose up to 30 days after last dose)
- 12 months' survival rate(from the date of the first dose up to 12 months)
- concentration of drug in serum(0.5 hour before first dose of Camrelizumab for Injection to 30 days after last dose)
- OS(from the date of the first dose to the date of death for any reason, up to 100 months)
- TTF(from the date of the first dose to the date of treatment termination, up to 6 months)
- Cmax(2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule)
- AUC(2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule)
- t1/2(2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule)
- ADA(the date of first dose up to 30 days after last dose)
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)(from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months)
- Tmax(2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule)
研究者
研究点 (1)
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