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Tests treatment safety and results for Advanced or Unresectable Hepatocellular Carcinoma (HCC)
Official title A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC
ClinicalTrials.gov ID: NCT07547553
What this study is testing
What is Will receive HH-009 injection 20 mg/kg, Q3W?
Will receive HH-009 injection 20 mg/kg, Q3W is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced or unresectable hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Participants with HCC who have experienced progressive disease after prio systemic therapy;
- Tumor tissue IHC testing for FGF19 was positive (confirmed by central laboratory);
You likely can't join if
- Participated in another clinical trial of investigational drugs or investigational medical devices within 28 days prior to the first dose; or...
- 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...
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Hong Kong, Hong Kong, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.