Clinical trial NCT06089330: A Study of JMT101 in Patients With Metastatic Colorectal Cancer
Official title: A Randomized, Controlled, Open-label Phase Ⅱ Study of The Safety, Tolerability and Efficacy of JMT101 and Irinotecan Combined With SG001 in Patients With Metastatic Colorectal Cancer (mCRC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer (mCRC)
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Metastatic Colorectal Cancer (mCRC).


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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: After1 cycle of treatment of the safety run-in phase patients (each cycle is 28 days)
measure: Overall response rate (ORR)
timeFrame: Up to approximately 2 years
measure: Incidence and severity of adverse events (AE) and serious adverse events (SAE)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
Study officials:
References: