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This is a Phase 2 study to evaluate the efficacy and safety of BB102, a highly selective and potent FGFR4 inhibitor, as monotherapy in subjects with advanced or unresectable FGF19-overexpressing hepatocellular carcinoma. This study has two phase: dose escalation phase and expansion phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BB102 treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BB102 | Drug | Oral BB102 Tablets in two dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. | From enrollment to the end of treatment assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. | From enrollment to the end of treatment assessed up to 12 months |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Wang, PhD | Contact | +86-15311443674 | qi.wang@broadenbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | 230031 | 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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Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
| From enrollment to the end of treatment assessed up to 12 months |
| Progression-free survival (PFS) | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. | From enrollment to the end of treatment assessed up to 12 months |
| Time-To-Progression (TTP) | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. | From enrollment to the end of treatment assessed up to 12 months |
| Number of subjects with adverse events (AEs) and serious adverse events (SAEs) | AEs and SAEs will be characterized by type, seriousness, relationship to study treatment, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) and timing. | From enrollment to the end of treatment assessed up to 12 months |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |