MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLepu Biopharma Co., Ltd.
About this trial
This is an open-label, multicenter, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MRG006A in combination with immune checkpoint inhibitors and targeted therapy in patients with advanced hepatocellular carcinoma (HCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and provide written informed consent, and comply with the requirements specified in the protocol.
Life expectancy ≥ 3 months.
Must provide tumor tissue specimens for GPC3 testing.
Histologically/cytologically confirmed hepatocellular carcinoma (HCC), Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B not amenable to curative surgery and/or locoregional therapy.
Disqualifiers
Prior histologically/cytologically confirmed diagnosis of hepatocellular carcinoma with fibrolamellar, sarcomatoid, cholangiocarcinoma, or other components.
History of hepatic failure or hepatic encephalopathy, or history of liver transplantation.
Pleural effusion, ascites, or pelvic effusion, or clinically significant pericardial effusion.
Acute or chronic active hepatitis B or hepatitis C infection.
Trial design
Design model
Parallel
Treatments tested in this trial
MRG006A
DrugAdministrated intravenously
Pucotenlimab
DrugAdministrated intravenously
Bevacizumab
DrugAdministrated intravenously
PD1/VEGF antibody
DrugAdministrated intravenously
TKI
DrugAdministrated intravenously
Treatment groups
160 Participants
are divided into 3 treatment groupsGroup A: MRG006A+Pucotenlimab + BevacizumabExperimental treatment 3 interventions
Group B: MRG006A+ PD1/VEGF antibodyExperimental treatment 2 interventions
Group C: MRG006A+ TKIExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Adverse events
Proportion of participants experiencing treatment-related adverse events as assessed by CTCAE v5.0
Time frame
Up to 2 years2
Recommended Phase 2 Dose
Evaluate RP2D based on the safety and efficacy of different dosage cohorts.
Time frame
1 yearSecondary outcomes
1
Peak concentration (Cmax)
Cmax of ADC, TAb, free payload will be measured.
Time frame
Up to 2 years2
Time to peak (Tmax)
Tmax of ADC, TAb, free payload will be measured.
Time frame
Up to 2 years3
Area under the concentration versus time curve (AUC)
AUC of ADC, TAb, free payload will be measured.
Time frame
Up to 2 years4
Half-life time (t1/2)
t1/2 of ADC, TAb, free payload will be measured.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov