Phase
Condition
Neoplasms
Treatment
ABSK021
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed solid tumors that have progressed on or intolerant tostandard therapy or whom no standard therapy exists
ECOG (electrocorticogram) performance status 0~1
Life expectancy ≥ 3 months
Adequate organ function and bone marrow function
For patients with tenosynovial giant cell tumor (TGCT) :
A diagnosis of TGCT [i ncluding pigmented villonodular synovitis (PVNS) or giantcell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmedeither by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worseningfunctional limitation or severe morbidity (locally advanced disease), with morbiditydetermined consensually by qualified personnel (eg, two surgeons or a multidisciplinary tumor board);
Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm isrequired), assessed from MRI scans;
Others
Exclusion
Exclusion Criteria:
Known allergy or hypersensitivity to any component of the investigational drugproduct Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colonystimulating factor 1 receptor) pathway inhibitors
Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment
Inability to take oral medication or significant nausea and vomiting, malabsorption,external biliary shunt, or significant bowel resection that would preclude adequateabsorption of oral medication
Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrinetherapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever isshorter) prior to initiation of study treatment (chemotherapy with nitrosourea ormitomycin should be 6 weeks prior to initiation of study treatment)
Major surgery within 4 weeks of the first dose of study drug and all surgical woundsmust be healed and free of infection or dehiscence
Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies,including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0)with the exception of alopecia and vitiligo
Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of thefirst dose of study drug
Concomitant use of strong inhibitors or inducers of CYP3A4
Active central nervous system (CNS) metastases
Impaired cardiac function or clinically significant cardiac disease
Patients with Gilbert's Syndrome or other underlying conditions that may lead to agreater likelihood of developing LFT(liver function test) abnormalities during thestudy
Known human immunodeficiency virus or active hepatitis B, or active hepatitis Cinfection
Refractory/uncontrolled ascites or pleural effusion
Pregnant or nursing
For patients with tenosynovial giant cell tumor (TGCT) :
Known allergy or hypersensitivity to any component of the investigational drugproduct
For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (notapplicable for TGCT patients in US)
Others
Study Design
Study Description
Connect with a study center
Beijing Jishuitan Hospital
Beijing, Beijing
ChinaActive - Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangzhou
ChinaActive - Recruiting
Hebei Medical University Third Hospital
Shijiazhuang, Hebei
ChinaCompleted
Henan Cancer Hospital
Zhengzhou, Henan
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou Universtity
Zhengzhou, Henan
ChinaCompleted
Jiangsu Province Hospital
Nanjing, Jiangsu
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
ChinaActive - Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning
ChinaCompleted
Huashan Hospital of Fudan University
Shanghai, Shanghai
ChinaCompleted
Shanghai Sixth People's Hospital
Shanghai, Shanghai
ChinaCompleted
Xi'an Hong Hui Hospital
Xian, Shanxi
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaActive - Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaActive - Recruiting
Precision NextGen Oncology
Beverly Hills, California 90212
United StatesActive - Recruiting
SCRI at HealthOne
Denver, Colorado 80218-1238
United StatesCompleted
The Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United StatesCompleted
MD Anderson Cancer Center
Houston, Texas 77030
United StatesCompleted
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