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New drug BB102 takes on Hard-to-Treat liver cancer

NCT ID NCT07239986

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests BB102, a targeted drug that blocks a protein called FGFR4, in 60 adults with advanced liver cancer that has not responded to standard treatments. Participants must have a specific genetic marker (FGF19 overexpression). The study will measure how well the drug shrinks tumors and controls the disease, while monitoring safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BB102 (a targeted drug that blocks FGFR4 protein)
What this could lead to
If it works, this could provide a new treatment option for people with advanced liver cancer that has not responded to other therapies.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Hefei, Anhui, 230031, China

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032, China

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