Actively Recruiting
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor
Led by Abbisko Therapeutics Co, Ltd · Updated on 2026-04-07
200
Participants Needed
32
Research Sites
461 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label phase 1 study with an escalation part and an expansion part.
CONDITIONS
Official Title
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 75 years old
- For escalation: confirmed advanced solid tumors progressed on or intolerant to standard therapy or no standard therapy exists
- For escalation: advanced hepatocellular carcinoma (HCC) with BCLC stage B or C and Child-Pugh score 5-6
- For expansion: confirmed HCC with BCLC stage B or C, progressed on or intolerant to or refused first line systemic therapy, and unsuitable for other standard therapies
- Archived tissue or biopsy available for FGF19 overexpression testing (positive for expansion)
- At least one measurable lesion (RECIST V1.1) for expansion patients
- Child-Pugh score 5-7 without hepatic encephalopathy or significant ascites
- ECOG performance status 0 or 1
- Life expectancy of at least 3 months
- Adequate organ and bone marrow function based on laboratory tests within 14 days prior to first dose
- HBV infection controlled with viral suppression before enrollment
- Agreement to use effective birth control during study and for 6 months after last dose for patients of childbearing potential
- Able to understand and provide informed consent and comply with study procedures
You will not qualify if you...
- Known allergy to components of ABSK-011
- Previous treatment with FGFR4 or pan-FGFR pathway inhibitors
- Active second primary cancer requiring treatment
- Active central nervous system metastases unless stable and controlled
- Liver tumor volume exceeding 50% of liver
- Inability to take oral medication or conditions affecting oral absorption
- Severe irritable bowel syndrome requiring treatment
- Prior organ transplant requiring anti-rejection drugs
- Recent major surgery, radiotherapy with high bone marrow exposure, or chemotherapy within specified timeframes
- Unresolved toxicities from prior cancer treatments above specified severity
- Use of strong CYP3A4 inhibitors or inducers within 14 days prior to study drug
- Significant cardiac disease or impaired heart function
- Active infection or unexplained fever over 38.5°C
- Active or recent gastrointestinal bleeding within 6 months
- Active hepatitis C infection requiring therapy or HBV/HCV co-infection
- Immunodeficiency conditions including HIV or active tuberculosis
- Other serious medical or mental conditions that could interfere with study participation
- Portal vein tumor thrombus type IV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
6
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Completed
8
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
9
The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Withdrawn
10
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
11
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Completed
12
Sun Yat Sen Memorial Hospital
Guangzhou, Guangdong, China
Completed
13
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
Completed
14
Weifang People's Hospital
Weifang, Hebei, China
Completed
15
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
Actively Recruiting
16
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Completed
17
Henan Cancer Hospital
Zhengzhou, Henan, China
Completed
18
Hubei Cancer Hospital
Wuhan, Hubei, China
Completed
19
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
20
Hunan Cancer Hospital
Changsha, Hunan, China
Completed
21
Hunan Provincial People's Hospital
Changsha, Hunan, China
Withdrawn
22
Suzhou University Affiliated Second Hospital
Suzhou, Jiangsu, China
Completed
23
Tonghua Central Hospital
Tonghua, Jilin, China
Completed
24
Shengjing Hospital of China medical university
Shenyang, Liaoning, China
Completed
25
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Completed
26
Jinan Central Hospital
Jinan, Shandong, China
Completed
27
Linyi Cancer Hospital
Linyi, Shandong, China
Completed
28
The First Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, China
Withdrawn
29
Mianyang Central Hospital
Mianyang, Sichuan, China
Actively Recruiting
30
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, China
Withdrawn
31
National Cheng Kung University Hospitals
Tainan, Taiwan
Completed
32
Nation Taiwan University Hospital
Taipei, Taiwan
Completed
Research Team
Y
Yuan Lu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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