NCT07277972尚未招募2 期
An Open-Label, Single-Arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection in Combination With Lenvatinib or Axitinib for the Treatment of Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma That Has Failed First-Line Systemic Therapy
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Objective response rate
研究概览
简要总结
The primary objective is to evaluate the improvement in Objective Response Rate (ORR) achieved with Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) in combination with Lenvatinib or Axitinib, in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have failed first-line systemic therapy.
详细描述
This single-arm, multicenter clinical study aims to evaluate the improvement in Objective Response Rate (ORR) achieved with Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) in combination with Lenvatinib or Axitinib, in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have failed first-line systemic therapy.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at Diagnosis: ≥18 years.
- •Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma.
- •Disease progression or intolerance during or following first-line systemic therapy.
- •ECOG Performance Status: 0-
- •At least one measurable lesion as defined by RECIST v1.
- •Life expectancy ≥12 weeks.
- •Adequate bone marrow function: White blood cell count > 4.0×10⁹/L, Hemoglobin > 90 g/L, Platelet count > 100×10⁹/L.
- •Adequate hepatic and renal function: Total bilirubin ≤ 1.5 × ULN; Aspartate aminotransferase and/or Alanine aminotransferase ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN.
- •Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 × ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN.
- •The patient must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as specified in the study protocol.
- •Female subjects of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, prescribed oral contraceptives taken regularly) from screening until 1 year after the end of treatment.
排除标准
- •Allergy to any component of macromolecular protein preparations; contraindications or hypersensitivity to any ingredient of Iparomlimab and Tuvonralimab Injection, Lenvatinib, or Axitinib.
- •Major surgery within 28 days prior to the first dose (excluding diagnostic laparoscopy; local surgery for isolated lesions is acceptable).
- •Positive Hepatitis B surface antigen (HBsAg) with HBV DNA >1×10³ copies/mL, or positive anti-Hepatitis C virus (HCV) antibody.
- •Positive anti-HIV antibody or a diagnosis of Acquired Immunodeficiency Syndrome (AIDS).
- •Active, known, or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disorders, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, asthma requiring bronchodilator therapy). Exceptions include type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
- •Renal failure requiring hemodialysis or peritoneal dialysis.
- •History of interstitial lung disease (ILD) or pneumonitis requiring oral or intravenous steroids within the past year; administration of Vancomycin within the past month.
- •Chronic systemic glucocorticoid therapy (at a dose equivalent to ≥10 mg prednisone daily) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible.
- •Uncontrolled cardiac disease, such as: 1) Heart failure, NYHA class ≥ II; 2) Unstable angina; 3) Myocardial infarction within the past year; 4) Supraventricular or ventricular arrhythmia requiring treatment or intervention.
- •Thromboembolic events within 6 months prior to the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), or pulmonary embolism, etc.
- •Known central nervous system metastases.
- •Urinalysis indicating urine protein ≥ +++ and confirmed 24-hour urinary protein >1.0 g.
- •Pregnant or lactating women (a pregnancy test should be considered for sexually active women of childbearing potential).
- •Prior or concurrent other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid.
- •Active infection requiring systemic therapy within one week.
- •Administration of a live vaccine within 30 days prior to the first dose of Iparomlimab and Tuvonralimab Injection.
- •History of organ transplantation or hematopoietic stem cell transplantation.
- •Any other condition that, in the investigator's assessment, may compromise patient safety or compliance, such as severe concomitant illnesses (including psychiatric disorders) requiring prompt treatment, severely abnormal laboratory test results, or the presence of other psychological, familial, or sociogeographic factors posing high-risk.
研究组 & 干预措施
Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib
Experimental
干预措施: Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib (Drug)
结局指标
主要结局
Objective response rate
时间窗: up to 12 month
the percentage of participants in the analysis population who had a CR(Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment.
次要结局
- Progression-Free Survival (PFS)(up to 12 month)
- Duration of Response(up to 12 month)
- Overall survival(up to 36 month)
- Adverse Events(up to 36 month)
研究者
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