RecruitingPhase 1NCT04192344
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
Sponsor
Abbisko Therapeutics Co, Ltd
Enrollment
276 participants
Start Date
Jan 20, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- Histologically confirmed solid tumors that have progressed on or intolerant to standard 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 giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);
- Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
- Others
Exclusion Criteria18
- Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating 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 adequate absorption of oral medication
- Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin 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 wounds must 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 the first 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 a greater likelihood of developing LFT(liver function test) abnormalities during the study
- Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection
- 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 drug product
- For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US）
- Others
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGABSK021
ABSK021 oral capsule
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04192344
Related Trials
Clinical and Genetic Studies of Li-Fraumeni Syndrome
NCT014434682 locations
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
NCT000710451 location
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
NCT033661161 location
Serious Gaming for Chemotherapy-induced Nausea and Vomiting
NCT058386382 locations
Evaluation and Implementation Preparation of a Proactive Palliative Care Model (ENABLE-SG)
NCT060444411 location