A Study of JMT101 in Patients With Metastatic Colorectal Cancer

Inclusion Criteria: 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. Exclusion Criteria: 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.