New hope for advanced liver cancer: first human trial of ABSK-011 begins

NCT ID NCT04906434

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called ABSK-011 in about 200 people with advanced solid tumors, especially liver cancer that has not responded to standard treatments. The main goals are to check the drug's safety, find the right dose, and see how the body processes it. Participants will receive the drug and be closely monitored for side effects and tumor response.

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Study facts

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

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 200 people

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

Started

Feb 2020

Expected to finish

Dec 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 to 75 years

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. Male or female, age 18 \~ 75 (include both ends, or other age range required by local regulations or IRB). 2. Escalation Part: Patients must have histological or cytological confirmed advanced solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists; and patients with advanced HCC must satisfy: 1. BCLC stage B or C and Child-Pugh score 5\~6 2. Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing Expansion Part: patients must have histological or cytological confirmed, BCLC stage B or C HCC, and have progressed on or intolerant to or have refused to receive or have no access to receive first line systemic therapy (by local guideline/regulation) and is unsuitable for other standard therapy(ies) (by local guideline/regulation) against HCC, and must satisfy: 1. Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive 2. Patient must have at least 1 measurable lesion (RECIST V1.1) 3. Child-Pugh score 5\~7 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention 3. ECOG performance status 0\~1 4. Life expectancy ≥ 3 months 5. Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug (without blood transfusion or medication with stimulation factors within 14 days before 1st dose): 1. Absolute neutrophil count (ANC) ≥1.5×109/L 2. Platelet count (PLT) ≥75×109/L 3. Hemoglobin (Hb) ≥80 g/L 4. Total bilirubin (TBIL) ≤1.5×ULN 5. Aspartate transaminase (AST) and alanine transaminase (ALT), ≤3×ULN (for patient with liver metastasis in escalation part or patient in expansion part: AST and AST ≤5×ULN) 6. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50 mL/min based on Cockcroft-Gault formula 6. Patients with HBV infection should follow local clinical practice and anti-HBV therapy should be performed to ensure adequate viral suppression (HBV-DNA \< 10000 IU/mL or equivalent copies/mL prior to enrollment). Patients are examined every cycle to monitor HBV-DNA levels. If virus reactivation occurred for patients without anti-viral treatment when enrolled, anti-HBV therapy will be started following local practice. 7. Non-surgically sterilized male or female patients of childbearing potential must agree to use effective methods of birth control during the study and for up to 6 months after the last dose of study drug. Non-surgically sterilized female patients of childbearing potential must in non-lactation period, and have a negative β-HCG test result within 7 days before first administration. 8. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. Exclusion Criteria: 1. Known allergy or hypersensitivity to any component of the investigational drug product. 2. Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor). 3. Has a known second primary malignancy required active treatment. 4. Has a known active central nervous system (CNS) metastases (if stable disease after treatment, free from or daily dexamethasone \<10 mg or other equivalent glucocorticoids can be enrolled). 5. Liver tumor volume accounts for ≥50% of the whole liver. 6. Inability to take oral medication or other factors significant preclude adequate absorption of oral medication, such as previously received total gastrectomy, residual gastric dysfunction after subtotal gastrectomy, short bowel syndrome after small bowel resection, active diarrhea required drug treatment, etc. 7. Severe irritable bowel syndrome requires drug therapy. 8. Prior organ transplantation requires anti-rejection drug therapy. 9. Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure \>30%), routine chemotherapy \<4 weeks (chemotherapy with nitrosourea or mitomycin \<6 weeks); oral chemotherapy, endocrine therapy, molecular targeted therapy or immunotherapy within ≤ 5 half-life or ≤ 4 weeks (whichever is shorter). 10. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE v5.0) with the exception of which inclusion criteria allowed, alopecia, vitiligo and neurotoxicity Grade ≤2 that investigator believe don't affect safety assessment. 11. Concomitant use of strong inhibitors or inducers of CYP3A4 (include grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice or products) within at least 14 day prior to the first dose of the study drug. 12. Impaired cardiac function or clinically significant cardiac disease, including any one of the following: 1. New York Heart Association class III or IV congestive heart failure, unstable angina, or myocardial infarction within 6 months before administration of the study drug; 2. Clinically significant cardiac arrhythmia requiring active therapy; 3. Uncontrolled hypertension; 4. Left ventricle ejection fraction\<50% 5. Prolongation of QTcF (average of three times of examine, male \> 450 ms, female \> 470 ms) (Note: QTc interval corrected by Frederica's formula) at screening, and other ECG abnormalities with clinical significant by the judge of the investigator. 13. Active infection or unexplained fever \> 38.5℃. 14. Active or record of gastrointestinal bleeding within 6 months (e.g. esophageal varices or ulcer bleeding). 15. Patients with active HCV infection (HCV-RNA\>103 copies/mL or following local clinical practice) and require concomitant anti-HCV therapy during the study; or HBV HCV co-infection. 16. History of immunodeficiency, including HIV serum test positive, or other acquired/congenital immunodeficiency disease, or active tuberculosis. 17. Any other clinically significant comorbidities, such as respiratory, metabolic, congenital, endocrine or central nervous system disease, or any other medical conditions, mental disturbances or social determinants, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks. 18. Combined with portal vein tumor thrombus of type IV.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma liver cancer neoplasm

As listed by the trial registrant

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

Advanced liver cancer

How to take part

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

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

11 sites in 2 countries. The list below names each one and where it is.
The official record

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

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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

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Beijing Tsinghua Changgung Hospital
RECRUITING

Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
RECRUITING

Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Henan University of Science and Technology
COMPLETED

Luoyang, Henan, China
Fujian Provincial Cancer Hospital
COMPLETED

Fuzhou, Fujian, China
General Hospital of Ningxia Medical University
COMPLETED

Yinchuan, Ningxia, China
Guangxi Zhuang Autonomous Region People's Hospital
COMPLETED

Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
RECRUITING

Haerbin, Heilongjiang, China
Henan Cancer Hospital
COMPLETED

Zhengzhou, Henan, China
Hubei Cancer Hospital
COMPLETED

Wuhan, Hubei, China
Hunan Cancer Hospital
COMPLETED

Changsha, Hunan, China
Hunan Provincial People's Hospital
WITHDRAWN

Changsha, Hunan, China
Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States

Contact Email: •••••@•••••
Jinan Central Hospital
COMPLETED

Jinan, Shandong, China
Linyi Cancer Hospital
COMPLETED

Linyi, Shandong, China
MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States

Contact Email: •••••@•••••
Mayo Clinic
RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic
RECRUITING

Jacksonville, Florida, 32224, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Mianyang Central Hospital
RECRUITING

Mianyang, Sichuan, China
Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612, United States
Nation Taiwan University Hospital
COMPLETED

Taipei, Taiwan
National Cheng Kung University Hospitals
COMPLETED

Tainan, Taiwan
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
WITHDRAWN

Ningbo, Zhejiang, China
Shengjing Hospital of China medical university
COMPLETED

Shenyang, Liaoning, China
Sun Yat Sen Memorial Hospital
COMPLETED

Guangzhou, Guangdong, China
Suzhou University Affiliated Second Hospital
COMPLETED

Suzhou, Jiangsu, China
The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army
WITHDRAWN

Beijing, Beijing Municipality, China
The First Affiliated Hospital of Bengbu Medical College
COMPLETED

Bengbu, Anhui, China
The First Affiliated Hospital of Xi'an Jiaotong University
WITHDRAWN

Xian, Shanxi, China
Tonghua Central Hospital
COMPLETED

Tonghua, Jilin, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
RECRUITING

Wuhan, Hubei, China
Weifang People's Hospital
COMPLETED

Weifang, Hebei, China

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