A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma

NCT07239986 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: BB102-HCC-II-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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)

Keywords

hepatocellular carcinoma; FGFR4; BB102

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Disease control rate (DCR)

  From enrollment to the end of treatment assessed up to 12 months

• Duration of response (DOR)

  From enrollment to the end of treatment assessed up to 12 months

• Progression-free survival (PFS)

  From enrollment to the end of treatment assessed up to 12 months

• Time-To-Progression (TTP)

  From enrollment to the end of treatment assessed up to 12 months

• Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

  From enrollment to the end of treatment assessed up to 12 months

Study Arms (1)

BB102 treatment

EXPERIMENTAL

Drug: BB102

Interventions

BB102 DRUG

Oral BB102 Tablets in two dosage

BB102 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Broadenbio Ltd., Co.: lead

Study Sites (2)

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

Hefei, Anhui, 230031, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Qi Wang, PhD

CONTACT

+86-15311443674; qi.wang@broadenbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)