Advanced or Unresectable Hepatocellular Carcinoma (HCC)Phase 1/2NCT07547553

A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC

A Phase 1/2 study testing Will receive HH-009 injection 20 mg/kg, Q3W and Will receive HH-009 injection 30 mg/kg, Q3W in people with Advanced or Unresectable Hepatocellular Carcinoma (HCC), run by Huahui Health at 21 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced or Unresectable Hepatocellular Carcinoma (HCC)
What is being tested?: Will receive HH-009 injection 20 mg/kg, Q3W and Will receive HH-009 injection 30 mg/kg, Q3W
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 21 sitesChina
Study dates: 19 May 2026to 30 Oct 2028
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntary participation in a clinical trial and signed informed consent.
Ages 18 to 75 years (inclusive of the boundaries), male or female.
Participants with advanced or unresectable HCC confirmed by pathological histology or diagnosed in accordance with the clinical criteria specified in the National Health Commission guidelines, with the following additional requirements:
Participants with HCC who have experienced progressive disease after prio systemic therapy;
Tumor tissue IHC testing for FGF19 was positive (confirmed by central laboratory);
Child-Pugh class A or class B (Child-Pugh score ≤7) ;

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Barcelona Clinic Liver Cancer (BCLC) stage B or C
ECOG score 0 or 1
Have at least one measurable lesion according to RECIST v1.1.
Life expectancy ≥ 12 weeks.
Adequate organ and bone marrow function.
Participants with HCV infection, whose HCV-RNA levels are above the lower limit of detection at the study site, are eligible if antiviral therapy is initiated prior to the first dose administration.
Participants with hepatitis B virus (HBV) infection must have HBV DNA < 104 cps/mL or 2,000 IU/mL.
Participants (including partners of the male participants) are willing to use effective contraception from the screening period until 6 months after the last investigational product administration.

Who cannot join

Participated in another clinical trial of investigational drugs or investigational medical devices within 28 days prior to the first dose; or received anticancer treatment within the past 4 weeks before the first dose, or within five half-lives of the drug (whichever is shorter), including but not limited to chemotherapy, radiotherapy (allowing palliative radiotherapy completed at least two weeks prior to investigational product administration), targeted therapy, immunotherapy, or endocrine therapy; or received traditional Chinese medicine with anticancer indications within one week before the first dose.
The previous antitumor treatment-related toxicity has not yet recovered to ≤ grade 1 or baseline level
Previously received FGFR inhibitors, including FGFR4 inhibitors and pan-FGFR inhibitors.
Undergone major surgery (except biopsy) within 4 weeks prior to the first study dose of the investigational product, or surgical wounds not fully healed.
Presence of moderate to large pleural or ascitic effusion accompanied by clinical symptoms, uncontrolled, or requiring repeated drainage.
Participants with active or a history of autoimmune diseases that are likely to recur (including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disorders, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or participants at high risk (e.g., participants who have undergone organ transplantation and require immunosuppressive therapy).

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Participants with a known history of other malignancies within 5 years prior to enrollment.
Leptomeningeal (meningeal) metastases, active brain metastases
Participants with known active tuberculosis or suspected active tuberculosis, or participants with active pneumonia requiring treatment.
History of clinically significant cardiovascular and cerebrovascular diseases.
Systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to the first dose.
History of human immunodeficiency virus (HIV) infection, or active infection requiring systemic treatment for more than 7 consecutive days within 14 days prior to the first dose administration.
Co-infection with HBV and HCV
Blood transfusion, treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, thrombopoietin, or erythropoietin initiated within 2 weeks prior to the first dose.
Bile acid-modulating medications that cannot be discontinued within 3 days prior to the first dose or within 5 half-lives of the drug (whichever is longer).
History of severe allergic reactions to other therapeutic antibody drugs; or known allergy to multiple substances or suffering from severe allergic diseases.
Pregnant or lactating females, or those with a positive blood pregnancy test.
Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results, or any other situation considered unsuitable for participation in this study.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiyu Zhang PM contact

18701650516

zhangxiyu@hhhbio.com

City, postcode or hospital

Sites recruiting now only

21 sites in 1 country

China21 sites, 21 recruiting

Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality
Recruiting
The Fifth Medical Center of the PLA General Hospital
Beijing, Beijing Municipality
Not yet recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
Not yet recruiting
Jilin University First Hospital
Changchun, Jilin
Not yet recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
Not yet recruiting
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong
Not yet recruiting
Shao Yi Fu Hospital, Affiliated to the School of Medicine of Zhejiang University
Hangzhou, Zhejiang
Not yet recruiting
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang
Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui
Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Not yet recruiting
Wells Prince Hospital of The Chinese University of Hong Kong
Hong Kong, Hong Kong
Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Not yet recruiting
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu
Recruiting
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi
Not yet recruiting
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi
Not yet recruiting
Shanghai Gaobo Tumor Hospital
Shanghai, Shanghai Municipality
Not yet recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Not yet recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning
Not yet recruiting
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality
Not yet recruiting
Henan Provincial Cancer Hospital
Zhengzhou, Henan
Not yet recruiting
The First Affiliated Hospital of Henan Medical University
Zhengzhou, Henan
Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-Label, Multicenter, Phase Ib/II Registration Trial to Observe and Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HH-009 Injection in FGF19-Positive Participants With Advanced or Unresectable Hepatocellular Carcinoma (HCC) Who Have Experienced Progressive Disease After Prior Systemic Therapy

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.

Read the detailed description

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).

Conditions: Advanced or Unresectable Hepatocellular Carcinoma (HCC)
Being tested: Will receive HH-009 injection 20 mg/kg, Q3W, Will receive HH-009 injection 30 mg/kg, Q3W
Keywords: Hepatocellular Carcinoma, FGF19 positive
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Will receive HH-009 injection 20 mg/kg, Q3WDrug
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W
Will receive HH-009 injection 30 mg/kg, Q3WDrug
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W

Study groups in NCT07547553
Study group	Role	What they receive
HH-009 20 mg/kg group	Experimental	Will receive HH-009 injection 20 mg/kg monotherapy, Q3W Receives: Drug: Will receive HH-009 injection 20 mg/kg, Q3W
HH-009 30 mg/kg group	Experimental	Will receive HH-009 injection 30 mg/kg monotherapy, Q3W Receives: Drug: Will receive HH-009 injection 30 mg/kg, Q3W

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS)
PFS assessed by investigators according to RECIST v1.1
Measured: Through study completion, up to 2 years

Secondary outcomes (11)

ORR
Defined as the proportion of participants achieving complete response (CR) or partial response (PR)
Measured: Through study completion, up to 2 years
DCR
Defined as the proportion of participants achieving CR, PR, or SD
Measured: Through study completion, up to 2 years
Time to progression (TTP)
Measured: Through study completion, up to 2 years
DOR
Measured: Through study completion, up to 2 years
Time to Response (TTR)
Measured: Through study completion, up to 2 years
overall survival (OS)
Measured: 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.
Measured: During study period
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC of HH-009 in plasma
Measured: Through study completion, up to 2 years
Maximum Plasma Concentration (Cmax)
Cmax of HH-009 in plasma
Measured: Through study completion, up to 2 years
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of HH-009 in plasma
Measured: Through study completion, up to 2 years
Apparent Terminal Elimination Half-life (T1/2)
T1/2 of HH-009 in plasma
Measured: Through study completion, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 202630 Oct 2028

First posted23 Apr 2026
Study start19 May 2026
Primary completion30 Oct 2028 (estimated)
Study completion30 Oct 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced or Unresectable Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07547553
Sponsor's protocol ID: HH009-201
Status last verified: Jun 2026
First submitted: 10 Apr 2026
Last updated: 16 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No