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New hope for liver cancer: targeted drug ABSK-011 enters phase 2 trial

NCT ID NCT07327034

Disease control Sponsor: Abbisko Therapeutics Co, Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called ABSK-011 for people with advanced liver cancer that has not responded to prior treatments. The drug targets a specific protein (FGF19) found in some tumors. About 141 participants will receive either ABSK-011 plus standard care or a placebo plus standard care to see if the drug helps shrink tumors or slow cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABSK-011
What this could lead to
If it works, this could offer a new treatment option for people with advanced liver cancer who have a specific genetic marker (FGF19 overexpression).
What could go wrong
This is an early Phase 2 trial with only 141 participants, so results may not apply to everyone. The drug may not shrink tumors or improve survival, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 141 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma (HCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    51 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, China

  • Affiliated Hospital ofJining Medical University

    RECRUITING

    Jining, Shandong, China

  • Anhui Provincial Cancer Hospital

    RECRUITING

    Hefei, Anhui, China

  • Beijing Tsinghua Changgung Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Chongqing university cancer hospital

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Eastern hepatobilliary surgery hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • First Affiliated Hospital of Gannan Medical University

    RECRUITING

    Ganzhou, Jiangxi, China

  • First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • General Hospital of Easten Theater Command

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, Ningxia, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, China

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, Guizhou, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, Liaoning, China

  • Liuzhou People's Hospital

    RECRUITING

    Liuzhou, Guangxi, China

  • Mianyang Central Hospital

    RECRUITING

    Mianyang, Sichuan, China

  • Nanjing Tianyinshan Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Nantong Tumor Hospital

    RECRUITING

    Nantong, Jiangsu, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Renji Hospital,Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    RECRUITING

    Luoyang, Henan, China

  • The First Affiliated Hospital of USTC

    RECRUITING

    Hefei, Anhui, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The First Affiliated Hospital with NanJing Medical University

    RECRUITING

    Nanjing, Jiangsu, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The Second Affiliated Hospital of Guilin Medical University

    RECRUITING

    Guilin, Guangxi, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • TianJin Cancer Hospital Airport Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Tongji Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

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