New pill shows promise for Hard-to-Treat cancers
NCT ID NCT06258408
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 78 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, China
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Nanfang Hospital
RECRUITINGGuangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Can turbocharged immune cells stop liver cancer from coming back?
- Experimental injection SHR-7787 put to the test against advanced solid tumors