NCT06089330尚未招募2 期
A Randomized, Controlled, Open-label Phase Ⅱ Study of The Safety, Tolerability and Efficacy of JMT101 and Irinotecan Combined With SG001 in Patients With Metastatic Colorectal Cancer (mCRC)
Shanghai JMT-Bio Inc.0 个研究点目标入组 102 人开始时间: 2024年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 主要终点
- Incidence and severity of adverse events (AE) and serious adverse events (SAE)
研究概览
简要总结
This study is a phase Ⅱ, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with Irinotecan and SG001 in Patients with Metastatic Colorectal Cancer (mCRC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ranged from 18 to 75 years old (inclusive), regardless of gender;
- •Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR/MSI-H;
- •Tumor tissue available for central laboratory testing;
- •Metastatic colorectal cancer with disease progression after 2nd line treatment; previously received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan; patients are allowed to previously receive EGFR and/or VEGF inhibitors, but not allowed to previously receive regorafenib, fruquintinib, or TAS-102;
- •Measurable disease according to RECIST1.1;
- •Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
- •Life expectancy ≥3 months
- •Adequate main organs and bone marrow function.
- •Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.
排除标准
- •Previously used anti PD-1, anti PD-L1, anti CTLA-4, or cellular immunotherapy;
- •Central nervous system metastasis or meningeal metastasis;
- •Patients with high risk of bleeding due to tumor invasion of important arteries;
- •Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
- •Patients who require continuous use of morphine-based drugs to control pain;
- •The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;
- •Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug;
- •Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, etc. within 21 days before the first dose of the study drug; radiotherapy within 2 weeks before the first dose of the study drug; Chinese medicine or Chinese patent medicine with anti-tumor effect within 1 week before the first dose of the study drug;
- •Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;
- •Use of immunosuppressive medications within 14 days prior to the first dose of study drug;
- •Those who use strong CYP3A4 inducers within 14 days before the first administration of the study drug, or those who use strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 1 week, or those who cannot suspend the use of the above drugs during the study;
- •Have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug;
- •Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;
- •Have a history of serious cardiovascular disease;
- •Previous or current presence of interstitial pneumonia/lung disease;
- •History of autoimmune diseases;
- •A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
- •Have infectious diseases requiring systemic anti-infective treatment;
- •Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;
- •Known presence of hypersensitivity or intolerance to any component of EGFR monoclonal antibody, PD-1 monoclonal antibody, irinotecan hydrochloride injection, regorafenib and its excipients;
- •Women during lactation or pregnancy; women with fertility tested positive for blood pregnancy within 7 days prior to enrollment in the trial;
- •Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration;
- •Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.
研究组 & 干预措施
JMT101+SG001+ Irinotecan
Experimental
干预措施: SG001 (Drug)
JMT101+SG001+ Irinotecan
Experimental
干预措施: JMT101 (Drug)
JMT101+SG001+ Irinotecan
Experimental
干预措施: Irinotecan (Drug)
JMT101+Irinotecan
Experimental
干预措施: JMT101 (Drug)
JMT101+Irinotecan
Experimental
干预措施: Irinotecan (Drug)
Regorafenib (Stivarga)
Active Comparator
干预措施: Regorafenib (Stivarga) (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
时间窗: Up to approximately 2 years
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Dose-limiting toxicity (DLT)
时间窗: After1 cycle of treatment of the safety run-in phase patients (each cycle is 28 days)
Overall response rate (ORR)
时间窗: Up to approximately 2 years
次要结局
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)
- Progression-free Survival (PFS)(Up to approximately 2 years)
研究者
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