Hepatocellular Carcinoma (HCC)Phase 2NCT07239986
A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma
A Phase 2 study testing BB102 in people with Hepatocellular Carcinoma (HCC), run by Broadenbio Ltd., Co. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- BB102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2025to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
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- (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.
Who cannot join
- (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.
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- (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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230031
Lianxin Liu, MD, +86-0551-62283760
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jian Zhou, MD, +86-021-64041990
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- BB102
- Keywords
- hepatocellular carcinoma, FGFR4, BB102
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB102Drug
Oral BB102 Tablets in two dosage
| Study group | Role | What they receive |
|---|---|---|
| BB102 treatment | Experimental | Not described Receives: Drug: BB102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: From enrollment to the end of treatment assessed up to 12 months
Secondary outcomes (5)
Disease control rate (DCR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: From enrollment to the end of treatment assessed up to 12 months
Duration of response (DOR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: From enrollment to the end of treatment assessed up to 12 months
Progression-free survival (PFS)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: From enrollment to the end of treatment assessed up to 12 months
Time-To-Progression (TTP)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: From enrollment to the end of treatment assessed up to 12 months
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
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.
Measured: From enrollment to the end of treatment assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Broadenbio Ltd., Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239986
- Sponsor's protocol ID
- BB102-HCC-II-01
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07239986
- Acronym / sponsor ID
- BB102-HCC-II-01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, FGFR4, BB102
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Broadenbio Ltd., Co.Industry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BB102 treatment | Experimental | Drug: BB102 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (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.
Key exclusion criteria (14 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB102Oral BB102 Tablets in two dosage | Drug | BB102 treatment |
Primary outcome
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.
5 secondary outcomes
Disease control rate (DCR)
Time frame: 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
Progression-free survival (PFS)
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BB102 in people with Hepatocellular Carcinoma (HCC), run by Broadenbio Ltd., Co. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Wang, PhD (+86-15311443674, qi.wang@broadenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: From enrollment to the end of treatment assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.