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

NCT07547553 | Not Yet Recruiting Phase 1

• 1 other identifier: HH009-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 21

Brief 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. 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.

Conditions

Advanced or Unresectable Hepatocellular Carcinoma (HCC)

Keywords

Hepatocellular Carcinoma; FGF19 positive

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS assessed by investigators according to RECIST v1.1

  Through study completion, up to 2 years

Secondary Outcomes (11)

• ORR

  Through study completion, up to 2 years

• DCR

  Through study completion, up to 2 years

• Time to progression (TTP)

  Through study completion, up to 2 years

• DOR

  Through study completion, up to 2 years

• Time to Response (TTR)

  Through study completion, up to 2 years

Other Outcomes (2)

• Dynamic changes in FGF19 in blood

  Through study completion, up to 2 years

• The incidence and changes in ADA.

  Through study completion, up to 2 years.

Study Arms (2)

HH-009 20 mg/kg group

EXPERIMENTAL

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

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

Drug: Will receive HH-009 injection 30 mg/kg, Q3W

Interventions

Will receive HH-009 injection 20 mg/kg, Q3W DRUG

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

HH-009 20 mg/kg group

Will receive HH-009 injection 30 mg/kg, Q3W DRUG

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

HH-009 30 mg/kg group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (21)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Location

Anhui Provincial Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Capital Medical University Affiliated Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Location

The Fifth Medical Center of the PLA General Hospital

Beijing, Beijing Municipality, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, China

Location

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, China

Location

Henan Provincial Cancer Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Henan Medical University

Zhengzhou, Henan, China

Location

Wells Prince Hospital of The Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Location

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Location

Jilin University First Hospital

Changchun, Jilin, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Location

Shanghai Gaobo Tumor Hospital

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

Shao Yi Fu Hospital, Affiliated to the School of Medicine of Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Xiyu Zhang PM

CONTACT

18701650516; zhangxiyu@hhhbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 23, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (21)