A Study of JMT101 in Patients With Metastatic Colorectal Cancer

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT06089330
Phase
PHASE2
Status
Unknown

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

Study Details

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).

Key Dates

Start date
Jan 31, 2024
Status verified
Oct 2023
Primary completion
Jul 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: JMT101+SG001+ Irinotecan
  • Experimental: JMT101+Irinotecan
  • Active Comparator: Regorafenib (Stivarga)

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: After1 cycle of treatment of the safety run-in phase patients (each cycle is 28 days) ]

Central Contacts

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