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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRG006A+Pucotenlimab + Bevacizumab | Experimental |
| |
| MRG006A+ PD1/VEGF antibody | Experimental |
| |
| MRG006A+ TKI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG006A | Drug | Administrated intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Proportion of participants experiencing treatment-related adverse events as assessed by CTCAE v5.0 | Up to 2 years |
| Recommended Phase 2 Dose | Evaluate RP2D based on the safety and efficacy of different dosage cohorts. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Cmax of ADC, TAb, free payload will be measured. | Up to 2 years |
| Time to peak (Tmax) | Tmax of ADC, TAb, free payload will be measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Program Director | Contact | 86-21- 67680899 | ra_bj@lepubiopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing You An Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| MRG006A | Drug | Administrated intravenously |
|
|
| MRG006A | Drug | Administrated intravenously |
|
|
| Up to 2 years |
| Area under the concentration versus time curve (AUC) | AUC of ADC, TAb, free payload will be measured. | Up to 2 years |
| Half-life time (t1/2) | t1/2 of ADC, TAb, free payload will be measured. | Up to 2 years |
| Anti-Drug Antibody characteristics | Proportion of subjects who develop treatment-emergent anti-drug antibody (ADA) positivity. | 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 | 6 months |
| Disease Control Rate | Proportion of patients with complete response/partial response and stable disease assessed by Response Criteria in Solid Tumor version 1.1 | 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 | Up to 2 years |
| Progression-Free Survival | Time between the start of study treatment and progressive disease or any cause of death | Up to 2 years |
| The Ethics Committee of Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | Beijing Municipality | 100021 | China |
|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
|
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | 350001 | China |
|
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
| The First Affiliated Hospital With Nanjing Medical University | Nanjing | Jiangsu | 210006 | China |
|
| Tianjin Cancer Hospital Airport Hospital | Tianjin | Tianjin Municipality | 300308 | China |
|
| Lishui Central Hospital | Lishui | Zhejiang | 323000 | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |