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New treatment option for Hepatocellular Carcinoma (HCC)
Official title ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression
ClinicalTrials.gov ID: NCT07327034
What this study is testing
What is ABSK-011+BSC?
ABSK-011+BSC is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma (hcc).
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 a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have received prior systemic therapy. Approximately 141 advanced or unresectable HCC patients with FGF19 overexpression who have received prior systemic therapy will be enrolled and randomized to experimental arm or control arm in a 2:1 ratio.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Patients should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patients...
- Patients (male or female) ≥ 18 years of age at the time of signing the informed consent form.
- Patients with advanced or unresectable HCC confirmed histologically/cytologically or clinically according to the American Association for the Study...
- Have received at least one prior PD- (L) 1 inhibitor approved as a single agent or in combination for the treatment of HCC and at least one mTKI...
- BCLC stage B(ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C.
You likely can't join if
- Known allergies or hypersensitivity to any component of the investigational product (ABSK-011 or placebo).
- Previous treatment with selective FGFR4 inhibitors.
- Known fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma.
- Previous anti-tumor therapy is ≤ 4 weeks from randomization.
- Major surgery within 4 weeks prior to randomization; or any surgical wound infection, dehiscence, or incomplete healing within 2 weeks prior to...
- History of second primary malignancies other than HCC within the first 5 years of screening.
See the full eligibility criteria
- Patients should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patients should be able and willing to comply with study visits and procedures...
- Patients (male or female) ≥ 18 years of age at the time of signing the informed consent form.
- Patients with advanced or unresectable HCC confirmed histologically/cytologically or clinically according to the American Association for the Study of Liver Diseases (AASLD) criteria (for patients with cirrhosis).
- Have received at least one prior PD- (L) 1 inhibitor approved as a single agent or in combination for the treatment of HCC and at least one mTKI approved for the treatment of HCC.
- BCLC stage B(ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C.
- Child-Pugh class A.
- Positive for FGF19 overexpression.
- At least 1 measurable lesion meeting RECIST v1.1 criteria.
- ECOG performance status 0 or 1.
- Life expectancy ≥ 3 months.
- Adequate control of blood pressure (BP) at screening.
- Adequate organ function and bone marrow function.
- Non-surgically sterilized male or female patients of childbearing potential must agree to use reliable contraception for at least 2 weeks prior to randomization until 1 month after the last dose of study treatment.
- Known allergies or hypersensitivity to any component of the investigational product (ABSK-011 or placebo).
- Previous treatment with selective FGFR4 inhibitors.
- Known fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma.
- Previous anti-tumor therapy is ≤ 4 weeks from randomization.
- Major surgery within 4 weeks prior to randomization; or any surgical wound infection, dehiscence, or incomplete healing within 2 weeks prior to randomization; Or major surgery is planned during study treatment.
- History of second primary malignancies other than HCC within the first 5 years of screening.
- Liver tumors as a percentage of whole liver ≥ 50% as judged by the investigator.
- Toxicities caused by prior chemotherapy, radiotherapy, and other anti-tumor therapies (including immunotherapy) did not recover to ≤ Grade 1 CTCAE v5.0.
- Imaging revealed HCC involving the main portal vein (Vp4), inferior vena cava, superior vena cava, superior mesenteric vein, or heart.
- Impaired cardiac function or clinically important heart disease.
- Patients coinfected with HBV and HCV.
- Known acquired immunodeficiency syndrome (AIDS) -associated disease or tested positive for HIV 1/2 antibodies.
- Active or documented gastrointestinal bleeding within 6 months prior to screening.
- Patients with intractable/uncontrolled pleural or pericardial effusion requiring intervention within 2 weeks prior to randomization and clinically significant ascites.
- Prior or current hepatic encephalopathy (any grade).
- Presence of meningeal or central nervous system (CNS) metastases.
- Previous organ transplant and anti-rejection drug therapy indicated.
- The factors that significantly affect the absorption of oral drugs.
- Receipt of P-gp transporter inhibitors or moderate, strong inhibitors or inducers of CYP3A4 within 2 weeks prior to randomization.
- Any serious acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks prior to randomization.
- Patient who cannot be assessed by contrast-enhanced CT and/or MRI due to allergy to computed tomography (CT) and/or magnetic resonance imaging (MRI) contrast media or other contraindications.
- Any other clinically significant comorbidities may affect the patient's health or safety, affect the signing of informed consent, affect protocol compliance, or interfere with the interpretation of the study results.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Guilin, Guangxi, China
- Liuzhou, Guangxi, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Harbin, Heilongjiang, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nantong, Jiangsu, China
- Xuzhou, Jiangsu, China
- Ganzhou, Jiangxi, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
+ 11 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Guilin, Guangxi, China and 25 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.