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
1 other identifier
interventional
141
1 country
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2025
Typical duration for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2025
CompletedFirst Submitted
Initial submission to the registry
November 26, 2025
CompletedFirst Posted
Study publicly available on registry
January 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
January 8, 2026
December 1, 2025
2 years
November 26, 2025
December 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ORR by BICR
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 Outcomes (8)
PFS
through study completion, , up to 2 years
DOR
through study completion, up to 2 years
DCR
through study completion, up to 2 years
TTP
through study completion, up to 2 years
TTR
through study completion, up to 2 years
- +3 more secondary outcomes
Other Outcomes (11)
Levels of FGF19 in blood samples
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Cmax
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Tmax
Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
- +8 more other outcomes
Study Arms (2)
Experimental arm
EXPERIMENTALABSK-011 plus BSC
Control arm
PLACEBO COMPARATORPlacebo plus BSC
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
- Patients (male or female) ≥ 18 years of age at the time of signing the informed consent form.
- 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).
- 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.
- BCLC stage B(ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C.
- Child-Pugh class A.
- Positive for FGF19 overexpression.
- At least 1 measurable lesion meeting RECIST v1.1 criteria.
- ECOG performance status 0 or 1.
- Life expectancy ≥ 3 months.
- Adequate control of blood pressure (BP) at screening.
- Adequate organ function and bone marrow function.
- 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.
You may not qualify if:
- Known allergies or hypersensitivity to any component of the investigational product (ABSK-011 or placebo).
- Previous treatment with selective FGFR4 inhibitors.
- Known fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma.
- Previous anti-tumor therapy is ≤ 4 weeks from randomization.
- 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.
- History of second primary malignancies other than HCC within the first 5 years of screening.
- Liver tumors as a percentage of whole liver ≥ 50% as judged by the investigator.
- Toxicities caused by prior chemotherapy, radiotherapy, and other anti-tumor therapies (including immunotherapy) did not recover to ≤ Grade 1 CTCAE v5.0.
- Imaging revealed HCC involving the main portal vein (Vp4), inferior vena cava, superior vena cava, superior mesenteric vein, or heart.
- Impaired cardiac function or clinically important heart disease.
- Patients coinfected with HBV and HCV.
- Known acquired immunodeficiency syndrome (AIDS) -associated disease or tested positive for HIV 1/2 antibodies.
- Active or documented gastrointestinal bleeding within 6 months prior to screening.
- Patients with intractable/uncontrolled pleural or pericardial effusion requiring intervention within 2 weeks prior to randomization and clinically significant ascites.
- Prior or current hepatic encephalopathy (any grade).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
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
Liuchow, 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
Tongji Hospital
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
General Hospital of Easten Theater Command
Nanjing, Jiangsu, China
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital with NanJing Medical University
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Cancer Hospital
Jinan, Shandong, China
Affiliated Hospital ofJining Medical University
Jining, Shandong, China
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Renji Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
TianJin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2025
First Posted
January 8, 2026
Study Start
June 13, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
January 8, 2026
Record last verified: 2025-12