NCT07061210尚未招募2 期
An Explorative Study of HRS-2189 Combined With Adebrelimab and BP102 for Metastatic Colorectal Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
To evaluate the safety and efficacy of HRS-2189 combined with Adebrelimab and BP102 in the treatment of metastatic colorectal 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
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
- •1.18-75 years; 2.Histological confirmed metastatic colorectal cancer; 3.ECOG PS 0-1; 4.At least one measurable lesion (according to RECIST1.1); 5.Patients voluntarily enroll in the study.
排除标准
- •The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);
- •Allergy to the study drug or any of its excipients;
- •Prior treatments or medications received before the first study treatment as follows:
- •Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is allowed).
- •Use of immunosuppressive drugs within 7 days before treatment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or an equivalent dose of other corticosteroids);
- •Administration of immunomodulatory drugs (such as thymosin, interferon, interleukin) within 3 weeks before treatment;
- •Vaccination with live attenuated vaccines within 28 days before treatment;
- •Other systemic anti-tumor therapies within 28 days before treatment;
- •Any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence;
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Active infection or unexplained fever >38.5°C within 4 weeks before the first dose or on the day of the first dose (fever due to tumor may be included in the study at the investigator's discretion)；
- •Within 6 months prior to study entry, any of the following conditions: myocardial infarction, severe/unstable angina, NYHA Class 2 or higher cardiac insufficiency, or clinically significant supraventricular/ventricular arrhythmia requiring clinical intervention; poorly controlled hypertension despite medication;
- •History of severe bleeding (>30 mL per episode) within 3 months, hemoptysis (>5 mL per episode) within 1 month, or arterial/venous thrombotic events within 6 months before the first dose;
- •Inability to swallow the study drug, or presence of factors affecting drug administration and absorption such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) or intestinal obstruction;
- •Pregnant or breastfeeding women, or subjects of reproductive potential unwilling to use effective contraception;
- •Presence of other severe physical or laboratory abnormalities that may increase the risk of study participation, interfere with study results, or patients deemed unsuitable for the study by the investigator.
研究组 & 干预措施
HRS-2189 + Adebrelimab + BP102
Experimental
干预措施: HRS-2189 (Drug)
HRS-2189 + Adebrelimab + BP102
Experimental
干预措施: Adebrelimab (Drug)
HRS-2189 + Adebrelimab + BP102
Experimental
干预措施: BP102 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: assessed up to 1 year
the proportion of patients with complete response or partial response, using RECIST v 1.1.
次要结局
- Progression-Free Survival (PFS)(assessed up to 1 year)
- Overall survival (OS)(assessed up to 2 year)
- Disease Control Rate (DCR)(assessed up to 1 year)
- Adverse events (AEs)(From the first drug administration to within 90 days for the last dose)
研究者
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