Status:
NOT_YET_RECRUITING
The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer
Lead Sponsor:
Shanghai JMT-Bio Inc.
Conditions:
Metastatic Colorectal Cancer (mCRC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 Metastat...
Detailed Description
This trial is conducted in patients with refractory metastatic colorectal cancer that has progressed after second-line or higher standard therapy. Eligible patients are randomized into two arms in a 1...
Eligibility Criteria
Inclusion
- 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;
- 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
- 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.
- 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\. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;
- 6\. Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug;
- 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;
- 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;
- 9\. Use of immunosuppressive medications within 14 days prior to the first dose of study drug;
- 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;
- 11\. Have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug;
- 12\. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;
- 13\. Have a history of serious cardiovascular disease;
- 14\. Previous or current presence of interstitial pneumonia/lung disease;
- 15\. History of autoimmune diseases;
- 16\. A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
- 17\. Have infectious diseases requiring systemic anti-infective treatment;
- 18\. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;
- 19\. Known presence of hypersensitivity or intolerance to any component of EGFR monoclonal antibody, irinotecan hydrochloride injection, regorafenib and its excipients;
- 20\. Women during lactation or pregnancy; women with fertility tested positive for blood pregnancy within 7 days prior to enrollment in the trial;
- 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;
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT07134205
Start Date
October 1 2025
End Date
October 1 2028
Last Update
August 21 2025
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