[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603260":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":27,"responsibleParty":42,"collaborators":27,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":27,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":27,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":27,"overallStatus":63,"whyStopped":27,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":27},{"fullName":5,"class":6},"Shanghai JMT-Bio Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"JMT101 + Irinotecan","EXPERIMENTAL","JMT101, 6 mg\u002Fkg, Irinotecan, 180mg\u002Fm\\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).",[13,14],"Drug: JMT101","Drug: Irinotecan",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of care","ACTIVE_COMPARATOR","28 day for one cycle.",[20],"Drug: Regorafenib",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","JMT101","JMT101, 6 mg\u002Fkg, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Irinotecan","Irinotecan, 180mg\u002Fm\\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Regorafenib","Regorafenib, 160 mg, taken orally once daily for the first 21 days of each 28-day cycle.",[16],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":43,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100603260","phase-3-the-study-of-jmt101-combined-with-irinotecan-as-a-3rd-line-treatment-in-metastatic-colorectal-cancer-100603260",false,"NCT07134205","The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer","A Randomized, Open-label, Multicenter Phase III Clinical Study of JMT101 in Combination With Irinotecan in Third-line and Beyond Treatment of Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Age ranged from 18 to 75 years old (inclusive), regardless of gender;\n* 2\\. Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR\u002FMSI-H;\n* 3\\. Tumor tissue available for central laboratory testing;\n* 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\u002For VEGF inhibitors, but not allowed to previously receive regorafenib, fruquintinib;\n* 5\\. Measurable disease according to RECIST1.1;\n* 6\\. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;\n* 7\\. Life expectancy ≥3 months\n* 8\\. Adequate main organs and bone marrow function.\n* 9\\. Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Participants who have been systematically treated with an EGFR inhibitor (such as cetuximab) within 4 months prior to the first dose of study drug.\n* 2\\. Central nervous system metastasis or meningeal metastasis;\n* 3\\. Patients with high risk of bleeding due to tumor invasion of important arteries;\n* 4\\. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;\n* 5\\. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;\n* 6\\. Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug;\n* 7\\. 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;\n* 8\\. 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;\n* 9\\. Use of immunosuppressive medications within 14 days prior to the first dose of study drug;\n* 10\\. 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 UGT1A9 inhibitors within 2 week, or those who cannot suspend the use of the above drugs during the study;\n* 11\\. Have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug;\n* 12\\. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;\n* 13\\. Have a history of serious cardiovascular disease;\n* 14\\. Previous or current presence of interstitial pneumonia\u002Flung disease;\n* 15\\. History of autoimmune diseases;\n* 16\\. A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;\n* 17\\. Have infectious diseases requiring systemic anti-infective treatment;\n* 18\\. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;\n* 19\\. Known presence of hypersensitivity or intolerance to any component of EGFR monoclonal antibody, irinotecan hydrochloride injection, regorafenib and its excipients;\n* 20\\. Women during lactation or pregnancy; women with fertility tested positive for blood pregnancy within 7 days prior to enrollment in the trial;\n* 21\\. 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;\n* 22\\. 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.","ALL","18 Years","75 Years",{"count":55,"type":56},252,"ESTIMATED","INTERVENTIONAL",[59],"PHASE3","This is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer.",[62],"Metastatic Colorectal Cancer (mCRC)","NOT_YET_RECRUITING","2025-08-14",{"date":66,"type":67},"2025-08-21","ACTUAL",{"date":69,"type":56},"2025-10-01",{"date":71,"type":56},"2028-10-01",{"name":5,"class":6}]