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)

Shanghai JMT-Bio Inc.0 sites102 target enrollmentJanuary 2024

ConditionsMetastatic Colorectal Cancer (mCRC)

InterventionsSG001 JMT101 Irinotecan Regorafenib (Stivarga)

DrugsJMT101 SG001 Irinotecan Regorafenib (Stivarga)

Overview

Phase: Phase 2
Intervention: SG001
Conditions: Metastatic Colorectal Cancer (mCRC)
Sponsor: Shanghai JMT-Bio Inc.
Enrollment: 102
Primary Endpoint: Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2024

End Date

December 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai JMT-Bio Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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;