A Study of JMT101 in Patients With Metastatic Colorectal Cancer

Shanghai JMT-Bio

Status and phase: Not yet enrolling; Phase 2

Conditions: Metastatic Colorectal Cancer (mCRC)

Treatments: Drug: JMT101; Drug: Regorafenib (Stivarga); Drug: SG001; Drug: Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06089330

JMT101-011

Details and patient eligibility

About

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).

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

JMT101+SG001+ Irinotecan

Experimental group

Treatment:

Drug: SG001

Drug: JMT101

Drug: Irinotecan

JMT101+Irinotecan

Experimental group

Treatment:

Drug: JMT101

Drug: Irinotecan

Regorafenib (Stivarga)

Active Comparator group

Treatment:

Drug: Regorafenib (Stivarga)