NCT07357220尚未招募1 期
A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of AK112 in Combination With VG2025 in Patients With Advanced Colorectal Cancer With Liver Metastases
Akeso0 个研究点目标入组 72 人开始时间: 2026年3月2日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
研究概览
简要总结
An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.
详细描述
This open-label, multicenter, phase Ib/II clinical study aims to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of AK112 in combination with VG2025, in the treatment of advanced colorectal cancer with liver metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Signed informed consent
- •Age≥18 years and ≤ 75 years
- •Histologically or cytologically confirmed unresectable colorectal cancer with liver metastases; adenocarcinoma type
- •Disease progression after first- or second-line standard therapy
- •At least one measurable disease based on RECIST v1.1
- •ECOG status of 0 or 1
- •Estimated life expectancy≥3 months
- •Adequate organ function
- •Patients with fertility are willing to use an adequate method of contraception
排除标准
- •Histologically or cytologically confirmed non-adenocarcinoma or mixed-type tumors with adenocarcinoma component ≤70%
- •Known dMMR or MSI-H
- •Known RAS or BRAF mutations
- •Participation in another clinical trial
- •Systemic anticancer therapy within 4 weeks, small molecule therapy within 2 weeks, antitumor traditional Chinese medicine within 2 weeks before first dose
- •Prior immunotherapy other than anti-PD-(L)1 agents
- •Live attenuated vaccine within 28 days before or during study treatment and 90 days after last dose
- •Active malignancy within the past 3 years
- •Known spinal cord compression, active brain or leptomeningeal metastases.
- •Significant bleeding events requiring transfusion, invasive intervention, or hospitalization within 3 months before first dose
- •Serious infection within 28 days, or systemic anti-infective therapy within 14 days before first dose (except antiviral therapy for hepatitis B/C)
- •Active herpesvirus infection with clinical manifestations
- •Active autoimmune disease
- •Known immunodeficiency
- •Known allergy to study drug or excipients, or history of severe allergic reactions to other vaccines
- •History of allogeneic organ or hematopoietic stem cell transplantation.
- •Clinically significant liver disease
- •Any other situations that are not suitable for inclusion in this study judged by investigator
研究者
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