A Study of JMT101 in Patients With Metastatic Colorectal Cancer

NCT ID: NCT06089330

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-12-31

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).

Conditions

Metastatic Colorectal Cancer (mCRC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JMT101+SG001+ Irinotecan

Group Type: EXPERIMENTAL

JMT101

Intervention Type: DRUG

JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

SG001

Intervention Type: DRUG

240 mg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

Irinotecan

Intervention Type: DRUG

180mg/m\^2, IV infusion once every two weeks (one treatment cycle is 4 weeks).

JMT101+Irinotecan

Group Type: EXPERIMENTAL

JMT101

Intervention Type: DRUG

JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

Irinotecan

Intervention Type: DRUG

180mg/m\^2, IV infusion once every two weeks (one treatment cycle is 4 weeks).

Regorafenib (Stivarga)

Group Type: ACTIVE_COMPARATOR

Regorafenib (Stivarga)

Intervention Type: DRUG

160 mg, taken orally once daily for the first 21 days of each 28-day cycle.

Interventions

JMT101

JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

Intervention Type: DRUG

SG001

240 mg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

Intervention Type: DRUG

Irinotecan

180mg/m\^2, IV infusion once every two weeks (one treatment cycle is 4 weeks).

Intervention Type: DRUG

Regorafenib (Stivarga)

160 mg, taken orally once daily for the first 21 days of each 28-day cycle.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai JMT-Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Other Identifiers

JMT101-011

Identifier Type: -

Identifier Source: org_study_id