NCT06089330

A Study of JMT101 in Patients With Metastatic Colorectal Cancer

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	JMT101	JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).
DRUG	SG001	240 mg, IV infusion once every two weeks (one treatment cycle is 4 weeks).
DRUG	Irinotecan	180mg/m\^2, IV infusion once every two weeks (one treatment cycle is 4 weeks).
DRUG	Regorafenib (Stivarga)	160 mg, taken orally once daily for the first 21 days of each 28-day cycle.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-07-01
• Completion: 2024-12-01
• First posted: 2023-10-18
• Last updated: 2023-10-18