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New pill shows promise for Hard-to-Treat cancers

NCT ID NCT06258408

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests an oral tablet called BB102 in people with advanced solid tumors that have not responded to standard treatments. The drug targets a specific protein (FGFR4) that may help control cancer growth. The study will check safety, side effects, and how the drug moves through the body, with a small group of 78 participants.

What this could mean

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

Active substance
BB102 (FGFR4 inhibitor) tablet
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors, especially liver cancer, that have specific genetic markers.
What could go wrong
This is a very early Phase 1 trial with only 78 participants, focused mainly on safety and dosing. It is too soon to know if BB102 will be effective or have manageable side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 78 people

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

Started

Dec 2022

Expected to finish

Dec 2026

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 to 78 years

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. For the dose escalation trial, histologically, cytologically confirmed or clinically confirmed advanced solid tumors patients who without available standard treatment, have disease progression on standard treatment or cannot tolerate standard treatment. For the expansion trial, histologically or cytologically confirmed FGF19 or FGFR4 positive advanced primary HCC or other advanced solid tumors patients who without available standard treatment, have disease progression on standard treatment or cannot tolerate standard treatment. 2. For the dose escalation trial, at least one evaluable lesion as defined by RECIST v1.1. For the expansion trial, at least one measurable lesion as defined by RECIST v1.1. 3. Eastern Cooperative Oncology Group (ECOG) score ≤1. 4. Expected survival ≥ 3 months. 5. Adequate organ function. 6. 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. 7. 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 4 weeks. 2. Prior use of selective FGFR4 inhibitor and/or pan-FGFR inhibitor therapy. 3. Use of cytotoxic chemotherapeutics within 4 weeks, OR use of state-approved Chinese traditional patent drugs/Chinese traditional drugs with an antitumor effect within 2 weeks. 4. Anti-tumor endocrine therapy, radiotherapy, interventional embolization, radiofrequency, proton therapy, radioimmunotherapy, immunotherapy or other biotherapies 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 2 weeks. 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 dual-source cancer within 5 years. 10. Presence of clinically symptomatic metastases to the central nervous system or meninges or other evidence showing that metastatic lesions in the central nervous system or meninges have not yet been controlled 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. Prior allogeneic stem cell transplantation, bone marrow transplantation or vital organ transplantation. 15. Presence of uncontrollable infectious disease, congenital immunodeficiency disease,acquired immunodeficiency syndrome, syphilis, active hepatitis B, hepatitis C virus (HCV) infection. 16. Severe active infection, including but not limited to bacteremia, severe pneumonia, etc., occurred within 2 weeks; an active infection that received therapeutic intravenous antibiotics within 2 weeks.

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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

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Nanfang Hospital

    RECRUITING

    Guangzhou, Guangdong, China

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