Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Phase 1

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

NCT04192344 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2020-01-20
Last updated
2026-03-19

Condition(s) studied

NeoplasmsTenosynovial Giant Cell Tumor

Investigational drug(s) / intervention(s)

ABSK021 →

ABSK021: ABSK021 oral capsule

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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) : 1. 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); 2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans; 3. Others Exclusion Criteria: * 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) : 1. Known allergy or hypersensitivity to any component of the investigational drug product 2. For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US) 3. Others

Primary outcome measure(s)

  • Incidence of DLTs — At the end of Cycle 1 (each cycle is 28 days)
    DLT(dose-limiting toxicity)
  • Incidence and Severity of AEs — Through study completion, an average of 6 months
    Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)

Trial sites (17)

FacilityCityRegionStatus
Precision NextGen Oncology Beverly Hills California Active Not Recruiting
SCRI at HealthOne Denver Colorado Completed
The Winship Cancer Institute of Emory University Atlanta Georgia Completed
MD Anderson Cancer Center Houston Texas Completed
Beijing Jishuitan Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Sun Yat-sen University Guangdong Guangzhou Recruiting
Hebei Medical University Third Hospital Shijiazhuang Hebei Completed
Henan Cancer Hospital Zhengzhou Henan Active Not Recruiting
The First Affiliated Hospital of Zhengzhou Universtity Zhengzhou Henan Completed
Jiangsu Province Hospital Nanjing Jiangsu Active Not Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Active Not Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Completed
Huashan Hospital of Fudan University Shanghai Shanghai Municipality Completed
Shanghai Sixth People's Hospital Shanghai Shanghai Municipality Completed
Xi'an Hong Hui Hospital Xian Shanxi Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04192344 on ClinicalTrials.gov ↗ ← All trials in the USA