This is a randomized, open-label, multicenter Phase Ib/II registration trial designed to evaluate the efficacy and safety of HH-009 in patients with FGF19-positive hepatocellular carcinoma (HCC). The study will also assess pharmacokinetics, pharmacodynamics, immunogenicity, and exploratory biomarkers. Approximately 30 patients with FGF19-positive advanced HCC will be enrolled. Eligible participants will be randomized 1:1 to receive HH-009 at either 20 mg/kg or 30 mg/kg Q3W as monotherapy. Treatment will continue until disease progression, unacceptable toxicity, initiation of new anticancer therapy, study withdrawal, completion of two years of treatment, loss to follow-up, death, or other protocol-specified reasons, whichever occurs first.
This study is a randomized, open-label, multi-center Phase Ib/II registration clinical trial. The study aims to evaluate the efficacy and safety of HH-009 in participants with FGF19-positive HCC; meanwhile, PK, PD, and immunogenicity profiles will be analyzed, and relevant biomarkers will be explored. Approximately 30 participants with advanced HCC who are FGF19-positive and have progressed after systemic therapy failure will be enrolled. Eligible participants meeting inclusion / exclusion criteria will be randomly assigned in a 1:1 ratio to two dose groups: HH-009 20 mg/kg or 30 mg/kg. Eligible participants will receive HH-009 monotherapy at a dose of 20 mg/kg or 30 mg/kg according to the randomly assigned HH-009 dose group, administered once every 3 weeks (Q3W), until progressive disease, intolerable toxicity (except when tolerability is restored after dose adjustment), initiation of new anticancer therapy, loss to follow-up, death, withdrawal from the study, completion of 2 years of study treatment, or any other reason (whichever occurs first).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGCapital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Fifth Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGMengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGNanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGAffiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITINGGuangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGHarbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITING...and 11 more locations
Progression-Free Survival (PFS)
PFS assessed by investigators according to RECIST v1.1
Time frame: Through study completion, up to 2 years
ORR
Defined as the proportion of participants achieving complete response (CR) or partial response (PR)
Time frame: Through study completion, up to 2 years
DCR
Defined as the proportion of participants achieving CR, PR, or SD
Time frame: Through study completion, up to 2 years
Time to progression (TTP)
Time frame: Through study completion, up to 2 years
DOR
Time frame: Through study completion, up to 2 years
Time to Response (TTR)
Time frame: Through study completion, up to 2 years
overall survival (OS)
Time frame: Through study completion, up to 3 years
Incidence of all AE, TEAE, and SAE
Incidence, relationship to the investigational drug, and severity of all AE, TEAE, and SAE.
Time frame: During study period
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC of HH-009 in plasma
Time frame: Through study completion, up to 2 years
Maximum Plasma Concentration (Cmax)
Cmax of HH-009 in plasma
Time frame: Through study completion, up to 2 years
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of HH-009 in plasma
Time frame: Through study completion, up to 2 years
Apparent Terminal Elimination Half-life (T1/2)
T1/2 of HH-009 in plasma
Time frame: Through study completion, up to 2 years
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