NCT07134205

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

A Randomized, Open-label, Multicenter Phase III Clinical Study of JMT101 in Combination With Irinotecan in Third-line and Beyond Treatment of Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This trial is conducted in patients with refractory metastatic colorectal cancer that has progressed after second-line or higher standard therapy. Eligible patients are randomized into two arms in a 1:1 ratio to receive JMT101 in combination with irinotecan or standard of care until disease progression, unacceptable toxicity or withdrawal of consent by the patient.

Conditions

• Metastatic Colorectal Cancer (mCRC)

Interventions

Type	Name	Description
DRUG	JMT101	JMT101, 6 mg/kg, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
DRUG	Irinotecan	Irinotecan, 180mg/m\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
DRUG	Regorafenib	Regorafenib, 160 mg, taken orally once daily for the first 21 days of each 28-day cycle.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-06-01
• Completion: 2028-10-01
• First posted: 2025-08-21
• Last updated: 2025-08-21