Not yet recruiting NCT07239986

A Phase 2 Study of BB102 in Patients With Hepatocellular Carcinoma

Phase II Interventional Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: BB102.
Who it may be relevant to: Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

Drug BB102
Oral BB102 Tablets in two dosage

Primary outcome measures

Objective response rate (ORR) [Time frame: From enrollment to the end of treatment assessed up to 12 months]

Secondary outcome measures (5)

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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Sequential
Masking: Open label
Primary purpose: Treatment

Study locations

China · 2 centers

The First Affiliated Hospital of University of Science and Technology of China — Hefei
Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT07239986 · BB102-HCC-II-01

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗