The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer
NCT07134205 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252
Last updated 2025-08-21
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.
Conditions
- Metastatic Colorectal Cancer (mCRC)
Interventions
- DRUG
-
JMT101
JMT101, 6 mg/kg, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
- DRUG
-
Irinotecan, 180mg/m\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
- DRUG
-
Regorafenib, 160 mg, taken orally once daily for the first 21 days of each 28-day cycle.
Sponsors & Collaborators
-
Shanghai JMT-Bio Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2027-06-01
- Completion
- 2028-10-01
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