The primary objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors.
This study aims to enroll 290 patients. Participants will be randomly assigned to receive treatment of MRG002 or investigator selected chemotherapy in a 1:1 ratio. The efficacy of MRG002 will be assessed by patient's OS, PFS and other indicators as compared to investigator selected chemotherapy. Additionally, this study will assess the pharmacokinetic profile, immunogenicity, safety, tolerability, and treatment compliance of MRG002.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
Administrated intravenously
Administrated intravenously
Administrated intravenously
Administrated intravenously
Administrated intravenously
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGOverall Survival (OS)
OS is defined as the time from the date of randomization until death of any cause.
Time frame: Baseline to study completion (up to 36 months)
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
PFS is defined as the duration from the date of randomization to the onset of tumor progression or death of any cause.
Time frame: Baseline to study completion (up to 36 months)
Objective Response Rate (ORR)
ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) according to RECIST v1.1.
Time frame: Baseline to study completion (up to 36 months)
Duration of Response (DoR)
DoR is defined as the time from first documented objective response (CR/PR) to the first onset of tumor progression or death of any nonsurgical cause.
Time frame: Baseline to study completion (up to 36 months)
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD).
Time frame: Baseline to study completion (up to 36 months)
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of patients who achieve CR, PR, and SD for ≥ 6 months.
Time frame: Baseline to study completion (up to 36 months)
Time to Response (TTR)
TTR is defined as the duration from randomization to the first documented objective response (CR/PR).
Time frame: Baseline to study completion (up to 36 months)
PFS by investigator
PFS is defined as the duration from the date of randomization to the onset of tumor progression or death of any cause.
Time frame: Baseline to study completion (up to 36 months)
Adverse Events (AEs)
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
Time frame: Baseline to 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve
Plot of drug concentration changing with time after drug administration.
Time frame: Baseline to 7 days after discontinuation of treatment
Anti-drug antibody (ADA)
The proportion of patients with positive ADA results and its titer.
Time frame: Baseline to 7 days after discontinuation of treatment
Neutralizing antibody (NAb)
The proportion of patients with positive NAb results and its titer.
Time frame: Baseline to 7 days after discontinuation of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.