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ABSK-011 plus supportive care versus placebo for previously treated advanced liver cancer 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

Phase 2 Interventional Abbisko Therapeutics Co, Ltd · NCT07327034

This trial tests whether adding ABSK-011 to best supportive care helps people with advanced hepatocellular carcinoma (HCC) whose tumors overexpress FGF19 after prior systemic therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment141 (estimated)
Ages18 Years and up
SexAll
SponsorAbbisko Therapeutics Co, Ltd Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations51 sites (Hefei, Anhui and 50 other locations)
Trial IDNCT07327034 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial enrolls about 141 patients with advanced or unresectable HCC and FGF19 overexpression who have received prior PD-(L)1 inhibitor and mTKI therapy. Participants are randomized 2:1 to receive ABSK-011 plus best supportive care or placebo plus best supportive care in 28-day cycles until disease progression, unacceptable toxicity, or other discontinuation reasons. Radiographic progression identified by the investigator requires immediate blinded independent central review (BICR), and unblinding is allowed if BICR confirms progression. The study measures safety and efficacy endpoints to determine whether ABSK-011 improves disease control compared with supportive care alone.

Who should consider this trial

Good fit: Adults (≥18) with advanced or unresectable HCC, Child-Pugh class A, BCLC stage B (ineligible for local therapy) or C, positive for FGF19 overexpression, and who have received at least one PD-(L)1 inhibitor and one mTKI are eligible.

Not a fit: Patients without FGF19 overexpression, with impaired liver function (Child-Pugh B or C), or who have not received the required prior systemic therapies are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, ABSK-011 could offer a targeted treatment option that prolongs disease control for patients with FGF19-overexpressing HCC compared with supportive care alone.

How similar studies have performed: Other therapies targeting the FGF19/FGFR4 pathway have shown promising responses in biomarker-selected HCC, supporting this targeted approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Hefei, Anhui and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatocellular CarcinomaHCCFGF19 overexpressionABSK-011
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.