NCT06472895尚未招募1 期
A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma
Peking University Cancer Hospital & Institute0 个研究点目标入组 30 人开始时间: 2024年7月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- ORR per RECIST v1.1 assessed by investigators
研究概览
简要总结
This is an open-label, single arm , Ib/II phase trial to evaluate the efficacy and safety of AK112（ivonescimab）monotherapy as first-line treatment for favourable risk advanced/metastatic renal cell carcinoma (a/m RCC).
Subjects will receive AK112 until disease progression, unacceptable toxic effects, death，a decision by the physician or patient to withdraw from the trial，or AK112 exposure over 2 years.
The study set dose exploration stage and dose expansion stage respectively. Firstly, include a few subjects for observation in dose exploration stage, and select appropriate dose to enter expansion, then continue to include more subjects to further assessment.
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
- •Provide written informed consent/assent for the trial.
- •Be ≥18 and ≤ 75 years of age on day of signing informed consent, no matter male or female.
- •IMDC favourable risk（IMDC score 0）.
- •ECOG PS 0-
- •Have estimated life expectancy of at least 3 months.
- •Have histologically or cytologically confirmed diagnosis of RCC with mainly clear cell carcinoma component.
- •Have received no prior systemic therapy for advanced RCC，Including but not limited to Immunotherapy, target therapy, chemotherapy, biological therapy, etc.
- •Note: Prior neoadjuvant/adjuvant therapies are acceptable if disease progression occurred > 6 months after last dosage of neoadjuvant/adjuvant treatment.
- •Have measurable disease per RECIST v1.1 .
- •Adequate organ function.
- •Contraception from entering the trial，until 120 days after the last administration of the investigational drug.
- •Willing to comply with the scheduled visits, treatment plans, and other requirements of the trial.
排除标准
- •non-clear cell renal cell carcinoma，nccRCC（e.g. chromophobe, papillary)
- •Has active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Subjects with diabetes type I, vitiligo, psoriasis, hypo-or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- •Has a known additional malignancy that has progressed or has required active treatment in the last 5 years.
- •Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ are not excluded.
- •Eligible for surgery.
- •History of severe bleeding or coagulation disorders.
- •History of abdominal fistula or gastrointestinal perforation related to anti VEGF therapy.
- •Has previously received systemic therapy.
- •Has newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids.
- •Had major surgery 4 weeks prior to receiving first dose of trial treatment.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to receiving first dose of trial treatment.
- •Has an active tuberculosis and syphilitic infection.
- •Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV antibodies).
- •Has known active Hepatitis B (e.g., Hepatitis B surface antigen [HBsAg] reactive and HBV-DNA>2000 IU/ml) or Hepatitis C virus (e.g., HCV RNA [qualitative] is detected).
- •Has been pregnant or breastfeeding.
- •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
treatment group
Experimental
Subjects will receive AK112 (RP2D, administered intravenously，Q3W)
干预措施: AK112 monotherapy (Drug)
结局指标
主要结局
ORR per RECIST v1.1 assessed by investigators
时间窗: Up to 2 years
ORR is the proportion of subjects with complete response(CR) and partial response(PR) , based on RECIST v1.1
次要结局
- DCR per RECIST v1.1 as assessed by investigators(Up to 2 years)
- Overall survival (OS)(4 years)
- Progression-free survival (PFS)(3 years)
- Duration of response (DOR)(Up to 2 years)
- Treatment-related adverse events(3 years)
研究者
Jun Guo
MD
Peking University Cancer Hospital & Institute
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