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
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, China
The Fifth Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, China
...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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