a study of jmt101 in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer (mCRC)

Summary: 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).


Eligibility criteria:
inclusion criteria: 1. age ranged from 18 to 75 years old (inclusive), regardless of gender; 2. pathological diagnosis as metastatic colorectal adenocarcinoma, with ras and braf wild-type and non-dmmr/msi-h; 3. tumor tissue available for central laboratory testing; 4. 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; 5. measurable disease according to recist1.1; 6. eastern cooperative oncology group (ecog) score 0-1 points; 7. life expectancy ≥3 months 8. adequate main organs and bone marrow function. 9. patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form. exclusion criteria: 1. previously used anti pd-1, anti pd-l1, anti ctla-4, or cellular immunotherapy; 2. central nervous system metastasis or meningeal metastasis; 3. patients with high risk of bleeding due to tumor invasion of important arteries; 4. uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion; 5. patients who require continuous use of morphine-based drugs to control pain; 6. the adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to ctcae 5.0 evaluation ≤ level 1; 7. diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug; 8. 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; 9. 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; 10. use of immunosuppressive medications within 14 days prior to the first dose of study drug; 11. 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; 12. have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug; 13. have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug; 14. have a history of serious cardiovascular disease; 15. previous or current presence of interstitial pneumonia/lung disease; 16. history of autoimmune diseases; 17. a history of immunodeficiency, including hiv testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation; 18. have infectious diseases requiring systemic anti-infective treatment; 19. active hepatitis b; hepatitis c infection; syphilis infection, active tuberculosis; 20. known presence of hypersensitivity or intolerance to any component of egfr monoclonal antibody, pd-1 monoclonal antibody, irinotecan hydrochloride injection, regorafenib and its excipients; 21. women during lactation or pregnancy; women with fertility tested positive for blood pregnancy within 7 days prior to enrollment in the trial; 22. 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; 23. 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.