Status:
UNKNOWN
A Study of JMT101 in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Shanghai JMT-Bio Inc.
Conditions:
Metastatic Colorectal Cancer (mCRC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 Met...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06089330
Start Date
January 1 2024
End Date
December 1 2024
Last Update
October 18 2023
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