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A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma | Clinical Trials | Clareo Health

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A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma

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

NCT07239986•Broadenbio Ltd., Co.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+4 more criteria

Locations (2)

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

Hefei, Anhui, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 1, 2025

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2028

Last Updated

November 20, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

BB102

DRUG

Contacts

Qi Wang, PhD

CONTACT

+86-15311443674 qi.wang@broadenbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

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