BridgeMD
Tests treatment safety and results for Neoplasms
Official title A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
ClinicalTrials.gov ID: NCT04192344
What this study is testing
What is ABSK021?
ABSK021 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor...
- 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...
- Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks...
- 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...
See the full eligibility 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) :
- 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...
- Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
- Others
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Denver, Colorado, United States
- Atlanta, Georgia, United States
- Houston, Texas, United States
- Beijing, Beijing Municipality, China
- Guangdong, Guangzhou, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Nanjing, Jiangsu, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Xian, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Denver, Colorado, United States; Atlanta, Georgia, United States; Houston, Texas, United States; Beijing, Beijing Municipality, China; Guangdong, Guangzhou, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.