Trial Filter
BETAAn intelligent search tool for clinical trials
Official Title
A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
Phase
Phase 1
Sponsor
Abbisko Therapeutics Co, Ltd
Enrollment
276
Timeline
Jan 2020 → Dec 2026
About This Study
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 Criteria
Inclusion Criteria
- 1Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
- 2ECOG (electrocorticogram) performance status 0\~1
- 3Life expectancy ≥ 3 months
- 4Adequate organ function and bone marrow function
- 5For patients with tenosynovial giant cell tumor (TGCT) :
- 6A 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);
- 7Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
- 8Others
Exclusion Criteria
- 1Known 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
- 2Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment
- 3Inability 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
- 4Previous 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)
- 5Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence
- 6Prior 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
- 7Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug
- 8Concomitant use of strong inhibitors or inducers of CYP3A4
- 9Active central nervous system (CNS) metastases
- 10Impaired cardiac function or clinically significant cardiac disease
- 11Patients 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
- 12Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection
- 13Refractory/uncontrolled ascites or pleural effusion
- 14Pregnant or nursing
- 15For patients with tenosynovial giant cell tumor (TGCT) :
- 16Known allergy or hypersensitivity to any component of the investigational drug product
- 17For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US）
- 18Others
Locations
17 sites participating in this study
The Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
Precision NextGen Oncology
Beverly Hills, California 90212
Kamlesh Sankhala, MD
SCRI at HealthOne
Denver, Colorado 80218-1238
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →