New hope for liver cancer: experimental drug HH-009 enters human trials

NCT ID NCT07547553

Disease control Sponsor: Huahui Health Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called HH-009 in people with advanced liver cancer that has worsened after other treatments. About 30 participants will receive one of two doses to see if it can slow or stop cancer growth. The goal is to find out if the drug is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: HH-009 injection
What this could lead to: If this trial succeeds, HH-009 could offer a new treatment option for people with advanced liver cancer who have not responded to other therapies.
What could go wrong: This is an early-phase trial with only 30 participants, so results may not apply to everyone. The drug may not work or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or unresectable hepatocellular carcinoma (HCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

21 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Tumor Hospital of Guangxi Medical University
NOT_YET_RECRUITING

Nanning, Guangxi, China
Anhui Provincial Hospital
NOT_YET_RECRUITING

Hefei, Anhui, China
Capital Medical University Affiliated Beijing Ditan Hospital
RECRUITING

Beijing, Beijing Municipality, China
Guangxi Zhuang Autonomous Region People's Hospital
NOT_YET_RECRUITING

Nanning, Guangxi, China
Harbin Medical University Affiliated Cancer Hospital
NOT_YET_RECRUITING

Harbin, Heilongjiang, China
Henan Provincial Cancer Hospital
NOT_YET_RECRUITING

Zhengzhou, Henan, China
Jiangxi Cancer Hospital
NOT_YET_RECRUITING

Nanchang, Jiangxi, China
Jilin University First Hospital
NOT_YET_RECRUITING

Changchun, Jilin, China
Liaoning Cancer Hospital
NOT_YET_RECRUITING

Shenyang, Liaoning, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
NOT_YET_RECRUITING

Fuzhou, Fujian, China
NanFang Hospital of Southern Medical University
NOT_YET_RECRUITING

Guangzhou, Guangdong, China
Nanjing Tianyinshan Hospital
RECRUITING

Nanjing, Jiangsu, China
Shanghai Gaobo Tumor Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, China
Shao Yi Fu Hospital, Affiliated to the School of Medicine of Zhejiang University
NOT_YET_RECRUITING

Hangzhou, Zhejiang, China
The Fifth Medical Center of the PLA General Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, China
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING

Hefei, Anhui, China
The First Affiliated Hospital of Bengbu Medical University
NOT_YET_RECRUITING

Bengbu, Anhui, China
The First Affiliated Hospital of Henan Medical University
RECRUITING

Zhengzhou, Henan, China
Tianjin Medical University Cancer Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, China
Wells Prince Hospital of The Chinese University of Hong Kong
NOT_YET_RECRUITING

Hong Kong, Hong Kong, China
Zhongshan Hospital Affiliated to Fudan University
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, China