Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma
ConditionHepato Cellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This study will evaluate the efficacy and safety of Becotatug vedotin, MRG003, in previously treated advanced hepatocellular carcinoma (HCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained.
Age ≥ 18 years at time of study entry.
Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
Disease progression after ≥1 line of PD-1/L1 inhibitors-based regimens.
Disqualifiers
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
Patients on a liver transplantation list or with advanced liver disease.
History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
Trial design
Design model
Single group
Treatments tested in this trial
MRG003
DrugMRG003 will be administered by IV, 2.3 mg/kg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: MRG003Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) in Cohort 1.
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.
Time frame
max 24 monthsSecondary outcomes
1
Objective Response Rate (ORR) in Cohort 2.
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.
Time frame
max 24 months2
Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD)
Time frame
max 24 months3
Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame
max 24 months4
Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed
Time frame
max 24 monthsSponsors and contacts
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Source ClinicalTrials.gov