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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression

A Randomized, Double-blind, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of ABSK-011 Plus Best Supportive Care (BSC) vs. Placebo Plus BSC in Previously Systemically Treated Advanced or Unresectable Hepatocellular Carcinoma Patients With FGF19 Overexpression

ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression (NCT07327034) is a Phase 2 interventional studying Hepatocellular Carcinoma (HCC), sponsored by Abbisko Therapeutics Co, Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have received prior systemic therapy. Approximately 141 advanced or unresectable HCC patients with FGF19 overexpression who have received prior systemic therapy will be enrolled and randomized to experimental arm or control arm in a 2:1 ratio. Patients will receive assigned study treatment, every 28-day treatment cycle within 1 day of randomization until disease progression, intolerable toxicity, start of new anti-tumor therapy, death, patient refuse to continue treatment, loss to follow-up, or other reasons leading to treatment discontinuation. Immediate BICR review is required for patients with radiographic disease progression as assessed by the investigator. If disease progression is assessed by BICR, the investigator is allowed to unblind after disease progression according to the protocol-specified procedures. After unblinding, patients in the experimental arm, study drug should be discontinued. Patients in the control arm may be transferred to receive ABSK-011 plus BSC after assessment.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hepatocellular Carcinoma (HCC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 141 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hepatocellular Carcinoma (HCC) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients should understand, sign, and date the written voluntary willing to sign a consent form form prior to any protocol-specific procedures performed. Patients should be able and willing to comply with study visits and procedures as per protocol. 2. Patients (male or female) ≥ 18 years of age at the time of signing the willing to sign a consent form form. 3. Patients with advanced or unresectable HCC confirmed histologically/cytologically or clinically according to the American Association for the Study of Liver Diseases (AASLD) criteria (for patients with cirrhosis). 4. Have received at least one prior PD- (L) 1 inhibitor approved as a single agent or in combination for the treatment of HCC and at least one mTKI approved for the treatment of HCC. 5. BCLC stage B(ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C. 6. Child-Pugh class A. 7. Positive for FGF19 overexpression. 8. At least 1 measurable lesion meeting RECIST v1.1 criteria. 9. You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. 10. Life expectancy ≥ 3 months. 11. Adequate control of blood pressure (BP) at screening. 12. your organs (liver, kidneys, etc.) are working well enough based on blood tests and bone marrow function. 13. Non-surgically sterilized male or female patients of childbearing potential must agree to use reliable contraception for at least 2 weeks prior to randomization until 1 month after the last dose of study treatment. Who Should NOT Join This Trial: 1. Known allergies or hypersensitivity to any component of the investigational product (ABSK-011 or placebo). 2. Previous treatment with selective FGFR4 inhibitors. 3. Known fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma. 4. Previous anti-tumor therapy is ≤ 4 weeks from randomization. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patients should be able and willing to comply with study visits and procedures as per protocol. 2. Patients (male or female) ≥ 18 years of age at the time of signing the informed consent form. 3. Patients with advanced or unresectable HCC confirmed histologically/cytologically or clinically according to the American Association for the Study of Liver Diseases (AASLD) criteria (for patients with cirrhosis). 4. Have received at least one prior PD- (L) 1 inhibitor approved as a single agent or in combination for the treatment of HCC and at least one mTKI approved for the treatment of HCC. 5. BCLC stage B(ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C. 6. Child-Pugh class A. 7. Positive for FGF19 overexpression. 8. At least 1 measurable lesion meeting RECIST v1.1 criteria. 9. ECOG performance status 0 or 1. 10. Life expectancy ≥ 3 months. 11. Adequate control of blood pressure (BP) at screening. 12. Adequate organ function and bone marrow function. 13. Non-surgically sterilized male or female patients of childbearing potential must agree to use reliable contraception for at least 2 weeks prior to randomization until 1 month after the last dose of study treatment. Exclusion Criteria: 1. Known allergies or hypersensitivity to any component of the investigational product (ABSK-011 or placebo). 2. Previous treatment with selective FGFR4 inhibitors. 3. Known fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma. 4. Previous anti-tumor therapy is ≤ 4 weeks from randomization. 5. Major surgery within 4 weeks prior to randomization; or any surgical wound infection, dehiscence, or incomplete healing within 2 weeks prior to randomization; Or major surgery is planned during study treatment. 6. History of second primary malignancies other than HCC within the first 5 years of screening. 7. Liver tumors as a percentage of whole liver ≥ 50% as judged by the investigator. 8. Toxicities caused by prior chemotherapy, radiotherapy, and other anti-tumor therapies (including immunotherapy) did not recover to ≤ Grade 1 CTCAE v5.0. 9. Imaging revealed HCC involving the main portal vein (Vp4), inferior vena cava, superior vena cava, superior mesenteric vein, or heart. 10. Impaired cardiac function or clinically important heart disease. 11. Patients coinfected with HBV and HCV. 12. Known acquired immunodeficiency syndrome (AIDS) -associated disease or tested positive for HIV 1/2 antibodies. 13. Active or documented gastrointestinal bleeding within 6 months prior to screening. 14. Patients with intractable/uncontrolled pleural or pericardial effusion requiring intervention within 2 weeks prior to randomization and clinically significant ascites. 15. Prior or current hepatic encephalopathy (any grade). 16. Presence of meningeal or central nervous system (CNS) metastases. 17. Previous organ transplant and anti-rejection drug therapy indicated. 18. The factors that significantly affect the absorption of oral drugs. 19. Receipt of P-gp transporter inhibitors or moderate, strong inhibitors or inducers of CYP3A4 within 2 weeks prior to randomization. 20. Any serious acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks prior to randomization. 21. Patient who cannot be assessed by contrast-enhanced CT and/or MRI due to allergy to computed tomography (CT) and/or magnetic resonance imaging (MRI) contrast media or other contraindications. 22. Any other clinically significant comorbidities may affect the patient's health or safety, affect the signing of informed consent, affect protocol compliance, or interfere with the interpretation of the study results.

Treatments Being Tested

DRUG

ABSK-011+BSC

ABSK-011 capsules will be provided and should be taken twice daily, with an interval of approximately 12 hours. The investigational product should be taken with food, with approximately 150 mL of water.

DRUG

Placebo+BSC

Placebo capsules will be provided and should be taken twice daily, with an interval of approximately 12 hours. The investigational product should be taken with food, with approximately 150 mL of water.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of USTC
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing university cancer hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07327034), the sponsor (Abbisko Therapeutics Co, Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07327034 clinical trial studying?

This is a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have received prior systemic therapy. Approximately 141 advanced or unresectable HCC patients with FGF19 overexpression who have received prior systemic therapy will be enrolled and randomized to experimental arm or control arm in a 2:1 ratio. Patients will receive assigned study treatment, every 28-day treatment cycle within 1 day of randomization until d… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07327034?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07327034?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07327034. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07327034. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.