A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma (NCT07239986) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma
China60 participantsStarted 2025-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Objective response rate (ORR)
Timeframe: From enrollment to the end of treatment assessed up to 12 months