The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai JMT-Bio Inc.

About this trial

This is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer.

Eligibility criteria

Qualifiers

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;

Disqualifiers

1. Participants who have been systematically treated with an EGFR inhibitor (such as cetuximab) within 4 months prior to the first dose of study drug.

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;

Trial design

Treatments tested in this trial

  • JMT101
  • Irinotecan
  • Regorafenib

Treatment groups

252 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators