Safety and Efficacy of Yiwoxidan Anti (AK112) Monotherapy in Patients With Metastatic Renal Clear Cell Carcinoma Who Are Intolerant to TKI Treatment: a Prospective, Single Arm, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is testing a new medicine called AK112 (Yivoximab) for people with advanced kidney cancer that has spread to other parts of the body (metastatic clear cell renal cell carcinoma). AK112 is a special kind of drug called a dual-target antibody that works in two ways: it helps the immune system fight cancer and blocks blood vessels that feed the tumor.
The goal of this study is to see how well AK112 works as a first-line treatment (before any other treatment) and how safe it is. We will look at how many patients' tumors shrink or stop growing, how long they live without their disease getting worse, and whether they have side effects.
This is a Phase II, single-arm, open-label study, meaning all participants will receive AK112, and everyone involved knows what treatment is being given. The study will take place at multiple hospitals across China and will include about 60 patients aged 18 to 75 years who have not received prior systemic treatment for advanced kidney cancer.
Participants will receive AK112 through an IV infusion every three weeks until the cancer progresses or side effects become too severe. They will have regular check-ups, including blood tests, imaging scans (like CT or MRI), and physical exams to monitor their health and response to treatment.
The study is expected to start in November 2023 and end in June 2027. Participation is voluntary, and all medical care related to the study will be provided at no cost. Participants may also be covered by clinical trial insurance in case of unexpected harm.
We hope this study will help find a better treatment option for people with advanced kidney cancer.
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
盲法说明
Not applicable. This is an open-label study with no masking of any role.
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
- •Age between 18 and 75 years, inclusive.
- •Histologically confirmed diagnosis of clear cell renal cell carcinoma (ccRCC).
- •Metastatic disease with at least one measurable lesion according to RECIST v1.1 criteria.
- •No prior systemic therapy for advanced or metastatic ccRCC.
- •ECOG Performance Status of 0 or
- •Expected survival ≥12 weeks.
- •Adequate organ function:
- •Hemoglobin ≥9 g/dL
- •Absolute neutrophil count ≥1.5 × 10⁹/L
- •Platelets ≥100 × 10⁹/L
- •Total bilirubin ≤1.5 × ULN
- •AST/ALT ≤2.5 × ULN (≤5.0 × ULN if liver metastases present)
- •Serum creatinine ≤1.5 × ULN or eGFR ≥60 mL/min/1.73m²
- •INR ≤1.5 or aPTT within normal limits
- •Female patients of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study and for 12 weeks after last dose.
- •Willing and able to provide written informed consent.
排除标准
- •1. Non-clear cell histology or mixed histology with non-clear cell component >25%.
- •2. Prior treatment with PD-1/PD-L1 inhibitors, VEGF/VEGFR inhibitors, or other immune checkpoint inhibitors.
- •3. Active autoimmune disease requiring systemic immunosuppressive therapy.
- •Uncontrolled hypertension (systolic BP >150 mmHg or diastolic BP >100 mmHg despite medication).
- •5. Significant cardiovascular disease including unstable angina, myocardial infarction, or congestive heart failure (NYHA Class III-IV) within 6 months.
- •6. Symptomatic central nervous system metastases or spinal cord compression.
- •Active infection including HBV, HCV, HIV, or active tuberculosis.
- •Known hypersensitivity to AK112 or its excipients.
- •Pregnancy or breastfeeding.
- •Any condition that may interfere with the interpretation of study results or pose an undue risk to the participant, as determined by the investigator.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From study start to data cutoff date (approximately 24 months)
The objective response rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria, assessed by independent radiology review. ORR will be evaluated at baseline and every 6 weeks thereafter until disease progression or withdrawal from the study. The primary endpoint will be analyzed in the intent-to-treat (ITT) population.
次要结局
- Disease Control Rate (DCR)(From study start to data cutoff date (approximately 24 months))
- Overall Survival (OS)(From first dose of study drug to death from any cause, up to 36 months)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(During treatment and up to 30 days after last dose)
- Changes in Laboratory Parameters(Baseline, every cycle, and at end of treatment; up to 24 months)
- Vital Signs Monitoring(At screening, baseline, every cycle, and at end of treatment; up to 24 months)
- Concomitant Medication Use(From screening until end of study (approximately 24 months))
研究者
ZHOU FANGJIAN
Professor
Sun Yat-sen University