A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma

NCT ID: NCT07239986

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-06-30

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.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BB102 treatment

Group Type: EXPERIMENTAL

BB102

Intervention Type: DRUG

Oral BB102 Tablets in two dosage

Interventions

BB102

Oral BB102 Tablets in two dosage

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Broadenbio Ltd., Co.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Qi Wang, PhD

Role: CONTACT

qi.wang@broadenbio.com

+86-15311443674

Facility Contacts

Lianxin Liu, MD

Role: primary

+86-0551-62283760

Jian Zhou, MD

Role: primary

+86-021-64041990

Other Identifiers

BB102-HCC-II-01

Identifier Type: -

Identifier Source: org_study_id