A Study of JMT101 in Patients With Metastatic Colorectal Cancer

Trial Title: A Study of JMT101 in Patients With Metastatic Colorectal Cancer

NCT ID: NCT06089330

Condition: Metastatic Colorectal Cancer (mCRC)

Conditions: Official terms:
Colorectal Neoplasms
Irinotecan

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: JMT101
Description: JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).
Arm group label: JMT101+Irinotecan
Arm group label: JMT101+SG001+ Irinotecan

Intervention type: Drug
Intervention name: SG001
Description: 240 mg, IV infusion once every two weeks (one treatment cycle is 4 weeks).
Arm group label: JMT101+SG001+ Irinotecan

Intervention type: Drug
Intervention name: Irinotecan
Description: 180mg/m^2, IV infusion once every two weeks (one treatment cycle is 4 weeks).
Arm group label: JMT101+Irinotecan
Arm group label: JMT101+SG001+ Irinotecan

Intervention type: Drug
Intervention name: Regorafenib (Stivarga)
Description: 160 mg, taken orally once daily for the first 21 days of each 28-day cycle.
Arm group label: Regorafenib (Stivarga)

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).

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: January 2024

Completion date: December 2024

Lead sponsor:
Agency: Shanghai JMT-Bio Inc.
Agency class: Industry

Source: Shanghai JMT-Bio Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06089330