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

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT07134205
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Cancer (mCRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Jul 2025
Primary completion
Jun 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JMT101 + Irinotecan
    JMT101, 6 mg/kg, Irinotecan, 180mg/m\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
  • Active Comparator: Standard of care
    28 day for one cycle.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 3 years ]

Central Contacts

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