Advanced Liver Cancer study: ABSK-011
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 oral medicine 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 study aims to find the safest dose of the drug and see how the body handles it.
- Who it's for
- People who have advanced liver cancer.
- What's involved
- Participants will receive the study drug and undergo regular medical tests to check for side effects.
- Time commitment
- The study has two parts, but the total time and number of visits are not specified in the provided text.
- 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).
- 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, 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
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
- Male or female, age 18 \~ 75 (include both ends, or other age range required by local regulations or IRB).
- 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, 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
- 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.
- Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.
- 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...
- 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 is enrolling
- 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
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Haerbin, Heilongjiang, China
- Wuhan, Hubei, China
- Mianyang, Sichuan, 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, but 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?
This study is enrolling now at 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 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.