A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma

Broadenbio Ltd., Co.

Status and phase

Not yet enrolling

Phase 2

Conditions

Hepatocellular Carcinoma (HCC)

Treatments

Drug: BB102

Study type

Interventional

Funder types

Industry

Identifiers

NCT07239986

BB102-HCC-II-01

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.