A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma

November 16, 2025 updated by: Broadenbio Ltd., Co.

An Open-label, Multicenter Phase 2 Clinical Study on the Efficacy and Safety of BB102 in Patients With Advanced or Unresectable FGF19-overexpressing Hepatocellular Carcinoma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contact:
          • Lianxin Liu, MD
          • Phone Number: +86-0551-62283760
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital
        • Contact:
          • Jian Zhou, MD
          • Phone Number: +86-021-64041990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BB102 treatment
Drug: BB102
Oral BB102 Tablets in two dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 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.
From enrollment to the end of treatment assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 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.
From enrollment to the end of treatment assessed up to 12 months
Duration of response (DOR)
Time Frame: 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.
From enrollment to the end of treatment assessed up to 12 months
Progression-free survival (PFS)
Time Frame: 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.
From enrollment to the end of treatment assessed up to 12 months
Time-To-Progression (TTP)
Time Frame: 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.
From enrollment to the end of treatment assessed up to 12 months
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 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.
From enrollment to the end of treatment assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Broadenbio Ltd., Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB102-HCC-II-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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