NCT07087158招募中2 期
A Multicenter, Randomized, Open-Label, Active-Controlled Phase II Study Evaluating the Efficacy and Safety of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma
Imbioray (Hangzhou) Biomedicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月8日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a multicenter, randomized, open-label, active-controlled Phase II clinical study evaluating the efficacy and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.
详细描述
This is a multicenter, randomized, open-label, active-controlled study. Eligible patients with Advanced Renal Cell Carcinoma who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 2:1 ratio to either the experimental arm or the control arm.
- Experimental arm: IBR854 in combination with Pazopanib
- Control arm: Pazopanib The primary endpoint is PFS per RECIST 1.1. Efficacy and safety datas will be continuously collected until criteria for discontinuation are met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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, age ≥ 18 years old
- •Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery.
- •Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma.
- •Expected survival period is at least 3 months.
- •ECOG performance status of 0 or 1, or KPS score of at least
- •Has measurable disease per RECIST 1.
- •Organ function should meet the following criteria:
- •Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelet (PLT) ≥90×10^9/L; Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days).
- •Albumin ≥ 30 g/L; Total bilirubin ≤1.5×ULN (for subjects with Gilbert's syndrome, it can be ≤3×ULN); ALT and AST ≤1.5×ULN (If liver metastasis is combined, ALT and AST≤3×ULN).
- •Creatinine (Cr) ≤1.5 × ULN; Creatinine clearance (Ccr) (to be calculated only when Cr > 1.5× ULN) > 50 ml/min (Cockcroft-Gault formula).
- •Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN.
- •Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures.
排除标准
- •Documented central nervous system metastases.
- •Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment.
- •Has received major surgery (grade 3 or 4 as defined in the Measures for the Administration of Clinical Application of Medical Technology) within 28 days before the first dose of study treatment and has not yet recovered from which; or any planned curative surgery for renal cell carcinoma during the study.
- •History of another malignancy within 5 years before the first dose of study treatment, except for Lung carcinoma in situ, low-risk early-stage prostate cancer, or cured basal-cell carcinoma, squamous-cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.
- •Clinically significant gastrointestinal abnormalities such as malabsorption syndrome, major gastric or small-bowel resection that may affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other conditions increasing the risk of perforation; or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the first dose of study treatment.
- •Systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents required within 2 weeks before the first dose or anticipated during study treatment, except for:
- •Topical, intranasal, or inhaled corticosteroids.
- •Corticosteroids as premedication for infusion-related or hypersensitivity reactions (e.g., premedication for CT imaging).
- •Replacement therapy such as levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency.
- •Low-dose corticosteroids for orthostatic hypotension.
- •Clinically significant cardiovascular or cerebrovascular disease documented by any of the following:
- •Ischemic stroke (excluding silent lacunar infarction) or severe thromboembolic event within 6 months before the first dose of study treatment.
- •Myocardial infarction, unstable angina, congestive heart failure, or clinically significant arrhythmia within 6 months before the first dose of study treatment.
- •New York Heart Association (NYHA) class ≥ II heart failure before the first dose of study treatment.
- •QTcF interval >450 ms (men) or >470 ms (women) before the first dose of study treatment.
- •Left-ventricular ejection fraction (LVEF) ≤50 % before the first dose of study treatment.
- •Prior organ transplant, except corneal transplant; prior allogeneic stem-cell transplant.
- •Hepatitis B surface antigen (HBsAg) positive with HBV DNA >500 IU/mL or >2,500 copies/mL, or hepatitis C antibody positive with detectable HCV RNA, or known HIV infection, or active tuberculosis.
- •Interstitial lung disease or non-infectious pneumonitis that is currently symptomatic or has previously required systemic corticosteroids, in the opinion of the investigator likely to interfere with toxicity assessment or management.
- •Any severe, progressive, or uncontrolled medical condition that, in the investigator's judgment, makes the subject unsuitable for the study, including but not limited to:
- •Infection requiring systemic therapy.
- •Symptomatic pleural, pericardial, or ascitic fluid requiring or having undergone drainage within 2 weeks before the first dose (minimal asymptomatic effusion, third-spacing due to hypoalbuminaemia, or cases where benefit outweighs risk may be allowed).
- •History of coagulopathy (e.g., deep-vein thrombosis) or severe bleeding diathesis; clinically significant bleeding event (e.g., gastrointestinal bleeding) within 1 month before the first dose.
- •History of severe psychiatric disorder.
- •Any other condition that, in the investigator's opinion, renders study participation riskier than beneficial.
- •Prior grade 3-4 immune-related adverse events that, in the investigator's judgment, should be excluded.
- •Severe allergic or hypersensitivity disorders, significant drug allergies (including to investigational agents), or known hypersensitivity to any component of the study drug, including severe reactions to monoclonal antibodies.
- •Participation in another clinical trial and receipt of an investigational agent within 28 days before the first dose of study treatment.
- •Clinically significant organ dysfunction or comorbidity likely to interfere with protocol adherence.
- •Live vaccine received within 30 days before the first dose, or planned during the study or within 1 month after the last dose.
- •Pregnant or breast-feeding women (women who agree to discontinue breast-feeding before signing informed consent may be enrolled).
- •Any other condition or circumstance that, in the investigator's opinion, unsuitable for participation.
研究组 & 干预措施
Experimental arm
Experimental
IBR854 + Pazopanib
干预措施: IBR854 (Drug)
Control arm
Active Comparator
Pazopanib
干预措施: Pazopanib (Drug)
Experimental arm
Experimental
IBR854 + Pazopanib
干预措施: Pazopanib (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Approximately 2 years
The time from randomization to the first radiologically confirmed disease progression or death from any cause (whichever occurs first).
次要结局
- Overall Survival (OS)(Approximately 4 years)
- Objective Response Rate (ORR)(Approximately 2 years)
- Disease Control Rate (DCR)(Approximately 2 years)
- Duration of Response (DoR)(Approximately 2 years)
- Adverse Events (AEs)(Approximately 2 years)
研究者
研究点 (2)
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