This is a Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MRG007 combination therapy in patients with advanced colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
MRG007 will be administrated as specified in the protocol.
5-Fluorouracil / Leucovorin Calcium will be administrated as specified in the protocol.
Bevacizumab will be administrated as specified in the protocol.
Peking University cancer Hospital
Beijing, Beijing Municipality, China
Dose Limiting Toxicity (DLT)
Time frame: From the first dose to 30 days after the last dose
Serious Adverse Events (SAEs)
Time frame: From the first dose to 30 days after the last dose
Adverse Event (AE)
Time frame: From the first dose to 30 days after the last dose
Recommended Phase 2 Dose(RP2D) and/or Maximum Tolerated Dose (MTD)
Time frame: From the first dose to 30 days after the last dose
Objective Response Rate (ORR)
Time frame: Assessments will be performed every 6 weeks (± 7 days) following the first dose.
Serum Concentration
Serum Concentration of ADC, TAb, free payload will be measured.
Time frame: up to 2 years
Anti-Drug Antibody (ADA)
The proportion of patients with positive ADA results.
Time frame: up to 2 years
Neutralizing antibody (NAb)
The proportion of patients with positive NAb results.
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: Through study completion, an average 2 years
Disease Control Rate (DCR)
Time frame: Through study completion, an average 2 years
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Oxaliplatin will be administrated as specified in the protocol.
PD-1/VEGF antibody will be administrated as specified in the protocol.
Capecitabine will be administrated as specified in the protocol.
Progression-Free Survival (PFS)
Time frame: Through study completion, an average 2 years
Overall Survival (OS)
Time frame: Through study completion, an average 2 years