Hepatocellular Carcinoma (HCC)
Conditions
Keywords
hepatocellular carcinoma, FGFR4, BB102
Brief summary
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.
Interventions
DRUGBB102
Oral BB102 Tablets in two dosage
Sponsors
Broadenbio Ltd., Co.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1) Age ≥ 18 years old, with no gender restrictions. * (2) Disease progressed after receiving at least one anti-angiogenic and/or immune checkpoint inhibitor (including PD-1, PD-L1, CTLA-4) therapy, or the treatment is not tolerable. * (3) Histologically confirmed primary HCC with FGF19 overexpression, which meets the Barcelona Clinic Liver Cancer (BCLC) staging criteria for patients with stage B suitable for systemic therapy or stage C. * (4) At least one measurable lesion as defined by RECIST v1.1. * (5) Eastern Cooperative Oncology Group (ECOG) score ≤1. * (6) Expected survival ≥ 3 months. * (7) Adequate organ function. * (8) Female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception from signing the ICF until 6 months after the last dose of study treatment. * (9) Fully informed of the study and voluntarily signed the informed consent form (ICF), and willing to follow and have the ability to complete all trial procedures.
Exclusion criteria
* (1) Use of systemic immunosuppressive or systemic cortisol (≥10 mg prednisone or other equivalent hormones) within 2 weeks. * (2) Prior use of selective FGFR4 inhibitor therapy. * (3) Use of Tyrosine kinase inhibitor within 2 weeks. * (4) Use of systemic chemotherapy, radiotherapy (\>30% bone marrow exposure), interventional embolization, ablation therapy and immunotherapycytotoxic chemotherapeutics within 4 weeks. * (5) Use of other clinical investigational drug or therapy that was not marketed within 4 weeks. * (6) The patient is receiving drugs or therapies prohibited in the protocol and cannot discontinue such use at least 7 days. * (7) Pregnant or lactating females. * (8) Presence of clinically significant gastrointestinal disorder that may affect the intake, transport, or absorption of the study drug at screening. * (9) Patient with history of a second primary malignancy other than hepatocellular carcinoma within 5 years. * (10) Presence of clinically symptomatic metastases to the central nervous system or meninges at screening, which, at the investigator's discretion, is not suitable for enrollment. * (11) History of severe neurological or psychiatric disorders, including epilepsy, dementia, moderate to severe depression, etc. * (12) Clinically significant and uncontrolled cardiovascular diseases. * (13) Pulmonary embolism within 6 months. * (14) Presence of uncontrollable infectious disease, congenital immunodeficiency disease,acquired immunodeficiency syndrome, syphilis, active hepatitis B, hepatitis C virus (HCV) infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | From enrollment to the end of treatment assessed up to 12 months | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | From enrollment to the end of treatment assessed up to 12 months | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. |
| Duration of response (DOR) | From enrollment to the end of treatment assessed up to 12 months | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. |
| Progression-free survival (PFS) | From enrollment to the end of treatment assessed up to 12 months | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. |
| Time-To-Progression (TTP) | From enrollment to the end of treatment assessed up to 12 months | Tumor response measured by radiologic imaging techniques at baseline and throughout the study. |
| Number of subjects with adverse events (AEs) and serious adverse events (SAEs) | From enrollment to the end of treatment assessed up to 12 months | 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. |
Countries
China
Contacts
Primary ContactQi Wang, PhD
Outcome results
None listed