Actively Recruiting
A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
Led by Abbisko Therapeutics Co, Ltd · Updated on 2026-03-19
276
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating oral ABSK021 in patients with advanced solid tumors to determine its safety, tolerability, and the recommended dose for further studies. This phase 1 open-label trial also aims to assess preliminary antitumor activity in these patients. The study includes patients whose tumors have progressed after standard treatment or who have no available standard therapy. Specific focus is also given to patients with tenosynovial giant cell tumor (TGCT). The study begins with a dose escalation phase where patients receive a single oral dose of ABSK021 followed by a 3-day break to assess safety and pharmacokinetics. After this run-in, patients take ABSK021 once daily in repeated 28-day cycles. The dose increases following "3+3" escalation rules until the maximum tolerated dose or recommended dose of expansion is found. An expansion phase will then further evaluate safety and tolerability at the recommended dose in selected tumor types. Participants will be monitored for dose-limiting toxicities and adverse events throughout the study, with the primary safety assessment at the end of the first 28-day cycle and ongoing evaluation for about 6 months. Researchers will also measure tumor progression, duration of response, disease control, and pharmacokinetic parameters such as peak concentration and half-life. Patients will undergo MRI scans, organ function tests, and performance status evaluations to track treatment effects and safety during the trial, which will continue until study completion or progression.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Histologically confirmed solid tumors that have progressed on or are intolerant to standard therapy or have no standard therapy
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ and bone marrow function
- For patients with tenosynovial giant cell tumor (TGCT), diagnosis confirmed by pathology with locally advanced disease where surgery would cause severe morbidity
- Measurable disease by MRI with minimum size of 2 cm for TGCT patients
You will not qualify if you...
- Known allergy or hypersensitivity to any component of the investigational drug
- Prior treatment with CSF-1 or CSF-1R pathway inhibitors
- Active additional malignancy progressing or requiring treatment within 3 years
- Inability to take oral medication due to nausea, vomiting, malabsorption, biliary shunt, or bowel resection
- Recent anti-cancer therapy within 4 weeks or 5 half-lives prior to study drug
- Major surgery within 4 weeks before first dose with unhealed wounds
- Unresolved toxicities from prior therapies above Grade 2 except alopecia and vitiligo
- Use of corticosteroids as anti-cancer therapy within 2 weeks prior to study drug
- 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 liver test abnormalities risk
- Known HIV or active hepatitis B or C infection
- Refractory or uncontrolled ascites or pleural effusion
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive a single dose of ABSK021 followed by a 3-day off period to assess safety and pharmacokinetics of the single dose.
1 visit for dosing and monitoring
Duration - Repeated 28-day cycles until maximum tolerated dose or recommended dose is identified and study completion
Participants take oral ABSK021 once daily in repeated 28-day cycles to evaluate safety, tolerability, and preliminary antitumor activity.
Visits at the start of each 28-day cycle with additional monitoring visits as needed
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
S
Siqing Fu, MD
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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