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Tests treatment safety and results for Advanced Liver Cancer
Official title A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor
ClinicalTrials.gov ID: NCT04906434
What this study is testing
What is ABSK-011?
ABSK-011 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced liver cancer.
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 with an escalation part and an expansion part.
- 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 to 75
You may be able to join if
- Male or female, age 18 \~ 75 (include both ends, or other age range required by local regulations or IRB).
- Escalation Part: Patients must have histological or cytological confirmed advanced solid tumors that have progressed on or intolerant to standard...
- BCLC stage B or C and Child-Pugh score 5\~6
- Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing Expansion Part: patients must have histological or...
- Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive
You likely can't join if
- Known allergy or hypersensitivity to any component of the investigational drug product.
- Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor).
- Has a known second primary malignancy required active treatment.
- Has a known active central nervous system (CNS) metastases (if stable disease after treatment, free from or daily dexamethasone \<10 mg or other...
- Liver tumor volume accounts for ≥50% of the whole liver.
- Inability to take oral medication or other factors significant preclude adequate absorption of oral medication, such as previously received total...
See the full eligibility criteria
Who can join
- Male or female, age 18 \~ 75 (include both ends, or other age range required by local regulations or IRB).
- Escalation Part: Patients must have histological or cytological confirmed advanced solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists; and patients with advanced...
- BCLC stage B or C and Child-Pugh score 5\~6
- Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing Expansion Part: patients must have histological or cytological confirmed, BCLC stage B or C HCC, and have progressed on...
- Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive
- Patient must have at least 1 measurable lesion (RECIST V1.1)
- Child-Pugh score 5\~7 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention
- ECOG performance status 0\~1
- Life expectancy ≥ 3 months
- Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug (without blood transfusion or medication with...
- Absolute neutrophil count (ANC) ≥1.5×109/L
- Platelet count (PLT) ≥75×109/L
- Hemoglobin (Hb) ≥80 g/L
- Total bilirubin (TBIL) ≤1.5×ULN
- Aspartate transaminase (AST) and alanine transaminase (ALT), ≤3×ULN (for patient with liver metastasis in escalation part or patient in expansion part: AST and AST ≤5×ULN)
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50 mL/min based on Cockcroft-Gault formula
- Patients with HBV infection should follow local clinical practice and anti-HBV therapy should be performed to ensure adequate viral suppression (HBV-DNA \< 10000 IU/mL or equivalent copies/mL prior to enrollment)...
- Non-surgically sterilized male or female patients of childbearing potential must agree to use effective methods of birth control during the study and for up to 6 months after the last dose of study drug. Non-surgically...
- Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as...
What rules you out
- Known allergy or hypersensitivity to any component of the investigational drug product.
- Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor).
- Has a known second primary malignancy required active treatment.
- Has a known active central nervous system (CNS) metastases (if stable disease after treatment, free from or daily dexamethasone \<10 mg or other equivalent glucocorticoids can be enrolled).
- Liver tumor volume accounts for ≥50% of the whole liver.
- Inability to take oral medication or other factors significant preclude adequate absorption of oral medication, such as previously received total gastrectomy, residual gastric dysfunction after subtotal gastrectomy...
- Severe irritable bowel syndrome requires drug therapy.
- Prior organ transplantation requires anti-rejection drug therapy.
- Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure \>30%), routine chemotherapy \<4 weeks (chemotherapy with nitrosourea or...
- Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE v5.0) with the exception of which inclusion criteria...
- Concomitant use of strong inhibitors or inducers of CYP3A4 (include grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice or products) within at least 14 day prior to the first...
- Impaired cardiac function or clinically significant cardiac disease, including any one of the following:
- New York Heart Association class III or IV congestive heart failure, unstable angina, or myocardial infarction within 6 months before administration of the study drug;
- Clinically significant cardiac arrhythmia requiring active therapy;
- Uncontrolled hypertension;
- Left ventricle ejection fraction\<50%
- Prolongation of QTcF (average of three times of examine, male \> 450 ms, female \> 470 ms) (Note: QTc interval corrected by Frederica's formula) at screening, and other ECG abnormalities with clinical significant by the...
- Active infection or unexplained fever \> 38.5℃.
- Active or record of gastrointestinal bleeding within 6 months (e.g. esophageal varices or ulcer bleeding).
- Patients with active HCV infection (HCV-RNA\>103 copies/mL or following local clinical practice) and require concomitant anti-HCV therapy during the study; or HBV HCV co-infection.
- History of immunodeficiency, including HIV serum test positive, or other acquired/congenital immunodeficiency disease, or active tuberculosis.
- Any other clinically significant comorbidities, such as respiratory, metabolic, congenital, endocrine or central nervous system disease, or any other medical conditions, mental disturbances or social determinants, which...
- Combined with portal vein tumor thrombus of type IV.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Houston, Texas, United States
- Bengbu, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Weifang, Hebei, China
- Haerbin, Heilongjiang, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Suzhou, Jiangsu, China
- Tonghua, Jilin, China
+ 9 more site(s).
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Rochester, Minnesota, United States; New York, New York, United States; Houston, Texas, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.