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Clinical Trials in China / NCT07327034
Recruiting Phase 2

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

NCT07327034 · tracked via the Priya Life Science China tracker
Sponsor
Abbisko Therapeutics Co, Ltd
Phase
Phase 2
Started
2025-06-13
Last updated
2026-01-08

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

ABSK-011+BSC →Placebo+BSC

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+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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Anhui Provincial Cancer Hospital Hefei Anhui Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
The First Affiliated Hospital of USTC Hefei Anhui Recruiting
The Second Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality Recruiting
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting
Chongqing university cancer hospital Chongqing Chongqing Municipality Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
The Second Affiliated Hospital of Guilin Medical University Guilin Guangxi Recruiting
Liuzhou People's Hospital Liuzhou Guangxi Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Recruiting
Guizhou Provincial People's Hospital Guiyang Guizhou Recruiting
Affiliated Cancer Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Tongji Hospital Wuhan Hubei Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
General Hospital of Easten Theater Command Nanjing Jiangsu Not Yet Recruiting
Nanjing Tianyinshan Hospital Nanjing Jiangsu Recruiting
The First Affiliated Hospital with NanJing Medical University Nanjing Jiangsu Recruiting
Nantong Tumor Hospital Nantong Jiangsu Recruiting
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu Recruiting
First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi Recruiting
Jiangxi Cancer Hospital Nanchang Jiangxi Recruiting
The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Jilin Cancer Hospital Changchun Jilin Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Recruiting
The First Hospital of China Medical University Shenyang Liaoning Recruiting
General Hospital of Ningxia Medical University Yinchuan Ningxia Recruiting
Shandong Cancer Hospital Jinan Shandong Recruiting
Affiliated Hospital ofJining Medical University Jining Shandong Recruiting
Eastern hepatobilliary surgery hospital Shanghai Shanghai Municipality Not Yet Recruiting

+ 11 more sites — see the full list on the official registry below.

More Abbisko Therapeutics Co, Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327034 on ClinicalTrials.gov ↗ ← All trials in China