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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Administrated intravenously
Administrated intravenously
Administrated intravenously
Beijing You An Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Ethics Committee of Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, Beijing Municipality, China
RECRUITINGAdverse events
Proportion of participants experiencing treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 2 years
Recommended Phase 2 Dose
Evaluate RP2D based on the safety and efficacy of different dosage cohorts.
Time frame: 1 year
Peak concentration (Cmax)
Cmax of ADC, TAb, free payload will be measured.
Time frame: Up to 2 years
Time to peak (Tmax)
Tmax of ADC, TAb, free payload will be measured.
Time frame: Up to 2 years
Area under the concentration versus time curve (AUC)
AUC of ADC, TAb, free payload will be measured.
Time frame: Up to 2 years
Half-life time (t1/2)
t1/2 of ADC, TAb, free payload will be measured.
Time frame: Up to 2 years
Anti-Drug Antibody characteristics
Proportion of subjects who develop treatment-emergent anti-drug antibody (ADA) positivity.
Time frame: Up to 2 years
Objective Response Rate
Proportion of patients with complete response/partial response assessed by Response Criteria in Solid Tumor version 1.1
Time frame: 6 months
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Administrated intravenously
Administrated intravenously
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital With Nanjing Medical University
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGTianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITINGLishui Central Hospital
Lishui, Zhejiang, China
NOT_YET_RECRUITINGDisease Control Rate
Proportion of patients with complete response/partial response and stable disease assessed by Response Criteria in Solid Tumor version 1.1
Time frame: 6 months
Duration of Response
The time from the first documentation of objective tumor response (CR or PR) until disease progression or death from any cause
Time frame: Up to 2 years
Progression-Free Survival
Time between the start of study treatment and progressive disease or any cause of death
Time frame: Up to 2 years