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

December 25, 2025 updated by: Abbisko Therapeutics Co, Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

141

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
      • Hefei, Anhui, China
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated hospital of USTC
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Guilin Medical University
        • Contact:
      • Liuchow, Guangxi, China
        • Recruiting
        • Liuzhou People's Hospital
        • Contact:
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Affiliated Cancer Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • General Hospital of Easten Theater Command
        • Contact:
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing Tianyinshan Hospital
        • Contact:
      • Nantong, Jiangsu, China
        • Recruiting
        • Nantong Tumor Hospital
        • Contact:
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning Cancer Hospital
        • Principal Investigator:
          • Jingdong Zhang
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Jining, Shandong, China
        • Recruiting
        • Affiliated Hospital ofJining Medical University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, Shanghai Municipality, China
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Eastern hepatobilliary surgery hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Renji Hospital,Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Cancer Hospital
        • Contact:
      • Xi’an, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Mianyang, Sichuan, China
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Cancer hospital Airport hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • the Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
ABSK-011 plus BSC
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.
Placebo Comparator: Control arm
Placebo plus BSC
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR by BICR
Time Frame: through study completion, up to 2 years
Objective response rate (ORR) assessed by Blinded Independent Central Review (BICR) per RECIST v1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR). Patients who receive crossover treatment or start a new anti-tumor therapy prior to achieve an objective response (PR or CR) will be considered as non-responders.
through study completion, up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: through study completion, , up to 2 years
Defined as the time (months) from randomization to disease progression or death due to any cause, whichever occurs first.
through study completion, , up to 2 years
DOR
Time Frame: through study completion, up to 2 years
Defined as the time (months) from the first documented objective response to disease progression or death due to any cause, whichever occurs first.
through study completion, up to 2 years
DCR
Time Frame: through study completion, up to 2 years
Defined as the proportion of patients achieving CR, PR, or SD (meeting the minimum criteria for SD lasting at least 6 weeks).
through study completion, up to 2 years
TTP
Time Frame: through study completion, up to 2 years
Defined as the time (months) from randomization to disease progression.
through study completion, up to 2 years
TTR
Time Frame: through study completion, up to 2 years
Defined as time (months) from randomization to first objective response.
through study completion, up to 2 years
OS
Time Frame: through study completion, up to 2 years
Defined as the time (months) from randomization to death due to any cause.
through study completion, up to 2 years
ORR by investigator
Time Frame: through study completion, up to 2 years
Objective response rate (ORR) assessed by the investigator per RECIST v1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR).
through study completion, up to 2 years
Adverse events
Time Frame: through study completion, up to 2 years

Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and incidence of adverse events leading to dose interruption, dose reduction, and discontinuation of study treatment.

Eastern Cooperative Oncology Group (ECOG) performance status (PS), laboratory tests, electrocardiogram (ECG), vital signs, and physical examination and changes from baseline.
through study completion, up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of FGF19 in blood samples
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Changes in selected PD markers before and after treatment.
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Cmax
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
maximum observed concentration
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Tmax
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
time to maximum observed concentration
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
AUC
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
area under the concentration-time curve
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
t1/2
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
elimination half-life
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Vz/F
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
apparent volume of distribution
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
CL/F
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
apparent oral clearance
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Cmax,ss
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
maximum observed concentration of steady-state
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Cmin,ss
Time Frame: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1,Cycle 5 Day 1, End of treatment (each cycle is 28 days)
minimum observed concentration of steady-state
Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1,Cycle 5 Day 1, End of treatment (each cycle is 28 days)
AUCss
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
area under the concentration-time curve of steady-state
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
AR
Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
accumulation rate
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbisko Therapeutics Co, Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABSK-011-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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