Clinical Trials in the USA / NCT04192344
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
Condition(s) studied
NeoplasmsTenosynovial Giant Cell Tumor
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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