Actively Recruiting
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
Led by Abbisko Therapeutics Co, Ltd · Updated on 2026-03-19
276
Participants Needed
17
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.
CONDITIONS
Official Title
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed solid tumors that have progressed on or are intolerant to standard therapy or have no standard therapy
- ECOG performance status of 0 to 1
- Life expectancy of at least 3 months
- Adequate organ and bone marrow function
- For tenosynovial giant cell tumor (TGCT) patients: histologically confirmed diagnosis where surgery would cause worsening function or severe morbidity
- Measurable disease of at least 2 cm based on MRI scans for TGCT patients
You will not qualify if you...
- Known allergy or hypersensitivity to any component of the investigational drug
- Previous treatment with CSF-1 or CSF-1R pathway inhibitors (except for TGCT patients in the US during expansion phase)
- Additional progressing malignancy requiring treatment within 3 years
- Inability to take oral medication due to significant nausea, vomiting, malabsorption, or bowel surgery
- Anti-cancer therapy within 4 weeks or 5 half-lives prior to study start (6 weeks for nitrosourea or mitomycin chemotherapy)
- Major surgery within 4 weeks before first dose, with unhealed or infected wounds
- Unresolved toxicities from prior therapies above Grade 2 severity (except alopecia and vitiligo)
- Use of corticosteroids as anti-cancer therapy within 2 weeks prior to study
- Use of strong CYP3A4 inhibitors or inducers
- Active central nervous system metastases
- Significant cardiac disease or impaired cardiac function
- Gilbert's Syndrome or conditions increasing risk of liver test abnormalities
- Known HIV or active hepatitis B or C infection
- Uncontrolled ascites or pleural effusion
- Pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Precision NextGen Oncology
Beverly Hills, California, United States, 90212
Active, Not Recruiting
2
SCRI at HealthOne
Denver, Colorado, United States, 80218-1238
Completed
3
The Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Completed
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Completed
5
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
6
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangzhou, China
Actively Recruiting
7
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Completed
8
Henan Cancer Hospital
Zhengzhou, Henan, China
Active, Not Recruiting
9
The First Affiliated Hospital of Zhengzhou Universtity
Zhengzhou, Henan, China
Completed
10
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Active, Not Recruiting
11
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Active, Not Recruiting
12
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Completed
13
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Completed
14
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Completed
15
Xi'an Hong Hui Hospital
Xian, Shanxi, China
Actively Recruiting
16
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
17
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
YUAN LU
CONTACT
S
Siqing Fu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here