AzTrials
AzTrials

Advanced Liver CancerPhase 1NCT04906434

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor

A Phase 1 study testing ABSK-011 in people with Advanced Liver Cancer, run by Abbisko Therapeutics Co, Ltd at 32 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label phase 1 study with an escalation part and an expansion part. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Liver Cancer
What is being tested?
ABSK-011
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
32 sitesin 3 countries
Study dates
26 Feb 2020to 31 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age 18 ~ 75 (include both ends, or other age range required by local regulations or IRB).
  • 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:
  • BCLC stage B or C and Child-Pugh score 5~6
  • 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:
  • Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive
Show all 20Show fewer
  • Patient must have at least 1 measurable lesion (RECIST V1.1)
  • Child-Pugh score 5~7 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention
  • ECOG performance status 0~1
  • Life expectancy ≥ 3 months
  • 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):
  • Absolute neutrophil count (ANC) ≥1.5×109/L
  • Platelet count (PLT) ≥75×109/L
  • Hemoglobin (Hb) ≥80 g/L
  • Total bilirubin (TBIL) ≤1.5×ULN
  • 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)
  • Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50 mL/min based on Cockcroft-Gault formula
  • 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.
  • 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.
  • 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.

Who cannot join

  • Known allergy or hypersensitivity to any component of the investigational drug product.
  • Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor).
  • Has a known second primary malignancy required active treatment.
  • 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).
  • Liver tumor volume accounts for ≥50% of the whole liver.
  • 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.
Show all 23Show fewer
  • Severe irritable bowel syndrome requires drug therapy.
  • Prior organ transplantation requires anti-rejection drug therapy.
  • 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).
  • 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.
  • 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.
  • Impaired cardiac function or clinically significant cardiac disease, including any one of the following:
  • 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;
  • Clinically significant cardiac arrhythmia requiring active therapy;
  • Uncontrolled hypertension;
  • Left ventricle ejection fraction<50%
  • 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.
  • Active infection or unexplained fever > 38.5℃.
  • Active or record of gastrointestinal bleeding within 6 months (e.g. esophageal varices or ulcer bleeding).
  • 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.
  • History of immunodeficiency, including HIV serum test positive, or other acquired/congenital immunodeficiency disease, or active tuberculosis.
  • 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.
  • Combined with portal vein tumor thrombus of type IV.

Trial locations and contacts

32 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Yuan Lu, Doctor contact

+86021-68910052

clinical@abbisko.cn

32 sites in 3 countries

China24 sites, 5 recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality

    Gong Li, Doctor

    Gong Li, Doctor

    Recruiting

  • The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army

    Beijing, Beijing Municipality

    Withdrawn

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

    Completed

  • Hunan Cancer Hospital

    Changsha, Hunan

    Completed

  • Hunan Provincial People's Hospital

    Changsha, Hunan

    Withdrawn

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

    Dewei Li, Doctor

    Dewei Li, Doctor

    Recruiting

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian

    Completed

  • Sun Yat Sen Memorial Hospital

    Guangzhou, Guangdong

    Completed

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang

    Yuxian Bai, Doctor

    Yuxian Bai, Doctor

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong

    Completed

  • Linyi Cancer Hospital

    Linyi, Shandong

    Completed

  • First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

    Completed

  • Mianyang Central Hospital

    Mianyang, Sichuan

    Xiaobo Du, Doctor

    Xiaobo Du, Doctor

    Recruiting

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning, Guangxi

    Completed

  • Ningbo Huamei Hospital, University of Chinese Academy of Sciences

    Ningbo, Zhejiang

    Withdrawn

  • Shengjing Hospital of China medical university

    Shenyang, Liaoning

    Completed

  • Suzhou University Affiliated Second Hospital

    Suzhou, Jiangsu

    Completed

  • Tonghua Central Hospital

    Tonghua, Jilin

    Completed

  • Weifang People's Hospital

    Weifang, Hebei

    Completed

  • Hubei Cancer Hospital

    Wuhan, Hubei

    Completed

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei

    Xiaoping Chen, Doctor

    Xiaoping Chen, Doctor

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi

    Withdrawn

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

    Completed

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Completed

Other trials in China

United States6 sites, 6 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Sunyoung Lee, MD, GIClinicalTrials@mdanderson.org

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Hani M. Babiker, MD, 855-776-0015

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Max Sung, MD, GICancerClinicalResearch@mssm.edu

    Recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Mitesh J. Borad, MD, 855-776-0015

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Nguyen H. Tran, MD, 855-776-0015

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Richard Kim, MD

    O'Neke Nickle, O'Neke.Nickle@moffitt.org

    Recruiting

Other trials in United States

Taiwan2 sites

  • National Cheng Kung University Hospitals

    Tainan

    Completed

  • Nation Taiwan University Hospital

    Taipei

    Completed

Other trials in Taiwan

About this study

Official title: A Phase 1, Open-Label Study of ABSK-011 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors

This is an open-label phase 1 study with an escalation part and an expansion part.

Read the detailed description

The escalation part will evaluate the safety, tolerability, PK and recommended dose of expansion (RDE) of oral ABSK-011 in patients with advanced solid tumors. The expansion part of oral ABSK-011 at RDE will be followed for further evaluating safety and tolerability in patients with FGF19 overexpression advanced HCC. Preliminary antitumor activity will also be assessed.

Being tested
ABSK-011

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABSK-011Drug

    During the escalation part, the administration of oral ABSK-011 will be guided by "3+3"design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level.

Study groups in NCT04906434
Study groupRoleWhat they receive
ABSK-011ExperimentalDuring the escalation part, all patients will first receive a single dose ABSK-011 (run-in period) at Day -2 and be followed by a 1-day off (2 days in all for run-in period) to access the PK of single-dose. Then, patients will continuously receive ABSK-011 once daily (QD) or twice daily (BID) in repeated 28-day cycles. Dose escalation will employ a "3+3" design except for the patient in the accelerated titration cohort. In expansion part, patients will be treated at the selected RDE dose level.
Receives: Drug: ABSK-011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of DLT

    Incidence of dose-limiting toxicities (DLTs) in Cycle 1

    Measured: From the starting dosing of study drug to the end of Cycle 1 (each cycle is 28 days) in escalation Part

  2. Incidence and severity of AEs, AESIs and SAEs

    Incidence and severity of adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs) (Common Terminology Criteria for Adverse Events, CTCAE 5.0)

    Measured: 30 days after last administration, an average of one half year

  3. dose reduction or discontinuation

    dose reduction or discontinuation of study drug due to toxicity

    Measured: through study completion, an average of one half year

  4. physical examinations changes from baseline

    BMI

    Measured: through study completion, an average of one half year

  5. ECOG performance status

    ECOG performance status

    Measured: through study completion, an average of one half year

  6. electrocardiograms (ECGs)

    QTc

    Measured: through study completion, an average of one half year

  7. echocardiograms changes from baseline

    EF%

    Measured: through study completion, an average of one half year

  8. vital signs changes from baseline

    Temperature

    Measured: through study completion, an average of one half year

  9. vital signs changes from baseline

    pulse

    Measured: through study completion, an average of one half year

  10. vital signs changes from baseline

    blood pressure

    Measured: through study completion, an average of one half year

Secondary outcomes (14)

  1. Cmax

    maximum observed concentration (Cmax)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  2. Tmax

    time to maximum observed concentration (Tmax)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  3. AUC

    area under the concentration-time curve (AUC)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  4. t1/2β

    elimination half-life (t1/2β)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  5. Vz/F

    apparent volume of distribution (Vz/F)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  6. CL/F

    apparent oral clearance (CL/F)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  7. Css_max

    maximum observed concentration of steady-state (Css_max)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  8. Css_min

    minimum observed concentration of steady-state (Css_min)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  9. AUCss

    area under the concentration-time curve of steady-state (AUCss)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  10. Rac

    accumulation rate (Rac)

    Measured: the end of Cycle 1 Day15 (each cycle is 28 days)

  11. ORR

    Evaluate the preliminary antitumor activity in patients with FGF19 overexpression advanced HCC and in patients with other types of advanced solid tumor

    Measured: throughout study completion, on average of half year

  12. DoR

    Duration of response (DoR): time from [PR] or [CR] to disease progression

    Measured: throughout study completion, on average of half year

  13. DCR

    Disease control rate (DCR): DCR = [CR] +[PR] + stable disease [SD]

    Measured: throughout study completion, on average of half year

  14. PFS

    Progression-free survival (PFS): time from the first day receive study drug to disease progression or death

    Measured: throughout study completion, on average of half year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2021
  2. Study start26 Feb 2020
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04906434
Sponsor's protocol ID
ABSK-011-101
Status last verified
Apr 2026
First submitted
21 Apr 2021
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABSK-011 in people with Advanced Liver Cancer, run by Abbisko Therapeutics Co, Ltd at 32 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China, United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuan Lu, Doctor (+86021-68910052, clinical@abbisko.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of DLT (time frame: From the starting dosing of study drug to the end of Cycle 1 (each cycle is 28 days) in escalation Part). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04906434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in