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

June 15, 2026 updated by: Huahui Health

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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) ;
    • 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HH-009 20 mg/kg group
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W
Drug: Will receive HH-009 injection 20 mg/kg, Q3W
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W
Experimental: HH-009 30 mg/kg group
Will receive HH-009 injection 30 mg/kg monotherapy, Q3W
Drug: Will receive HH-009 injection 30 mg/kg, Q3W
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Through study completion, up to 2 years
PFS assessed by investigators according to RECIST v1.1
Through study completion, up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Through study completion, up to 2 years
Defined as the proportion of participants achieving complete response (CR) or partial response (PR)
Through study completion, up to 2 years
DCR
Time Frame: Through study completion, up to 2 years
Defined as the proportion of participants achieving CR, PR, or SD
Through study completion, up to 2 years
Time to progression (TTP)
Time Frame: Through study completion, up to 2 years
Through study completion, up to 2 years
DOR
Time Frame: Through study completion, up to 2 years
Through study completion, up to 2 years
Time to Response (TTR)
Time Frame: Through study completion, up to 2 years
Through study completion, up to 2 years
overall survival (OS)
Time Frame: Through study completion, up to 3 years
Through study completion, up to 3 years
Incidence of all AE, TEAE, and SAE
Time Frame: During study period
Incidence, relationship to the investigational drug, and severity of all AE, TEAE, and SAE.
During study period
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time Frame: Through study completion, up to 2 years
AUC of HH-009 in plasma
Through study completion, up to 2 years
Maximum Plasma Concentration (Cmax)
Time Frame: Through study completion, up to 2 years
Cmax of HH-009 in plasma
Through study completion, up to 2 years
Time to Reach Maximum Plasma Concentration (Tmax)
Time Frame: Through study completion, up to 2 years
Tmax of HH-009 in plasma
Through study completion, up to 2 years
Apparent Terminal Elimination Half-life (T1/2)
Time Frame: Through study completion, up to 2 years
T1/2 of HH-009 in plasma
Through study completion, up to 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dynamic changes in FGF19 in blood
Time Frame: Through study completion, up to 2 years
Changes in selected PD markers before and after treatment.
Through study completion, up to 2 years
The incidence and changes in ADA.
Time Frame: Through study completion, up to 2 years.
Through study completion, up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huahui Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HH009-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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