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Phase Ib: Dose exploration: To assess the safety, tolerability, and determine the recommended Phase 2 dose (RP2D) of BC3402 in combination with durvalumab in subjects with advanced hepatocellular carcinoma (HCC) Phase II: Dose Expansion: To assess the antitumor activity of BC3402 in combination with durvalumab in subjects with advanced HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BC3402+Durvalumab | Experimental | Subjects will receive BC3402 and Durvalumab in a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BC3402 injection | Drug | Intravenous infusion, once every 2 weeks, 4 weeks/cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events | To assess the incidence of dose limiting toxicity (DLT) events at different doses of BC3402 in combination with durvalumab in the treatment of advanced HCC | 28 Days |
| Phase Ib: Dose Exploration Part-Safety | To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC. | 2 years |
| Phase II: Dose Expansion Part-objective response rate (ORR) | To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1) | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Fan, MD | Contact | +86021-64041990 | fan.jia@zs-hospital.sh.cn | |
| Tianshu Liu, MD | Contact | +86 13681973996 | liu.tianshu@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jia Fan, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | 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 |
|---|---|
| C000613593 | durvalumab |
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| Durvalumab injection |
| Drug |
Intravenous infusion, once every 4 weeks, 4 weeks/cycle. |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |