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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
JMT101, 6 mg/kg, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
Irinotecan, 180mg/m\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
Regorafenib, 160 mg, taken orally once daily for the first 21 days of each 28-day cycle.
Progression-free Survival (PFS)
defined as the time from randomization to the first occurrence of disease progression as determined by the BIRC with use of RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Overall response rate (ORR)
determined by the BIRC and investigator with use of RECIST v1.1
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
determined by the BIRC and investigator with use of RECIST v1.1
Time frame: Up to approximately 2 years
Duration of response (DOR)
determined by the BIRC and investigator with use of RECIST v1.1
Time frame: Up to approximately 2 years
Progression-free Survival (PFS)
defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause.
Time frame: Up to approximately 5 years
Incidence and severity of AEs
Incidence and severity of adverse events (AE). Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: Up to approximately 2 years
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Serum concentration of JMT101
Serum concentration and immunogenicity of JMT101
Time frame: Up to approximately 2 years
Serum immunogenicity of JMT101
Immunogenicity of JMT101
Time frame: Up to approximately 2 years
To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
use EORTC QLQ-C30 questionnaire and the EQ-5D-5L questionnaire
Time frame: Up to approximately 2 years
Drug resistance
Gene Variations Detected by ctDNA and Drug Resistance Biomarkers
Time frame: Up to approximately 2 years