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New treatment option for HCC - Hepatocellular Carcinoma
Official title Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07310173
What this study is testing
What is AST-3424?
AST-3424 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hcc - hepatocellular carcinoma.
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
- The goal of this clinical trial is to learn if drug AST-3424 works to treat AKR1C3 high expressing advanced hepatocellular carcinoma after failure of systemic therapy with immune checkpoint inhibitors. The main question it aims to answer is: Does AST-3424 prolong survival in patients with AKR1C3-high Expressing advanced Hepatocellular Carcinoma who have progressed after immune checkpoint inhibitors based therapies?
- Phase 2: a mid-size study of how well it works
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
- Patients with pathologically confirmed advanced hepatocellular carcinoma (HCC).
- Documented disease progression confirmed by medical imaging after failure of prior systemic therapy regimens containing immune checkpoint inhibitors...
- Barcelona Clinic Liver Cancer (BCLC) stage B or C; ineligible for or refusing surgical resection or locoregional liver therapies (including...
- Child-Pugh class A or B liver function (score ≤ 7), with no history of hepatic encephalopathy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
You likely can't join if
- Patients with intrahepatic cholangiocarcinoma, dual-phenotype hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, or carcinosarcoma.
- Untreated active central nervous system (CNS) metastases. people with CNS metastases who have received adequate treatment, achieved stable disease...
- A history of other malignant tumors within 2 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the lung...
- A history of severe cardiovascular and cerebrovascular diseases.
- Has received anti-tumor therapies including locoregional radiotherapy, chemotherapy, immunotherapy, or targeted therapy within 4 weeks or 5...
- Has received major surgery other than diagnostic procedures or locoregional therapy targeting liver lesions within 4 weeks prior to the first dose.
See the full eligibility criteria
Who can join
- Patients with pathologically confirmed advanced hepatocellular carcinoma (HCC).
- Documented disease progression confirmed by medical imaging after failure of prior systemic therapy regimens containing immune checkpoint inhibitors (ICIs).
- Barcelona Clinic Liver Cancer (BCLC) stage B or C; ineligible for or refusing surgical resection or locoregional liver therapies (including transarterial intervention and ablation).
- Child-Pugh class A or B liver function (score ≤ 7), with no history of hepatic encephalopathy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Expected survival ≥ 3 months.
- Availability of pathological tissue blocks or sections (including archived samples) for AKR1C3 expression and related biomarker analysis. Immunohistochemistry (IHC) results must confirm high expression of AKR1C3.
- Adequate organ function.
- For people positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb): HBV DNA level must be \< 2000 IU/mL or 10⁴ copies/mL people must be receiving anti-HBV therapy . This therapy must be...
- Female people of childbearing potential must be non-lactating and have a negative pregnancy test result within 7 days prior to treatment initiation. A positive urine pregnancy test result must be confirmed by a serum...
- Female and male people of childbearing potential must agree to use effective contraceptive measures from the time of study enrollment until 6 months after the last dose of study drug.
- people must voluntarily participate in the study, provide written informed consent after a full understanding of the study details, and have good compliance to cooperate with study treatment, observation, and follow-up...
What rules you out
- Patients with intrahepatic cholangiocarcinoma, dual-phenotype hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, or carcinosarcoma.
- Untreated active central nervous system (CNS) metastases. people with CNS metastases who have received adequate treatment, achieved stable disease for at least 4 weeks confirmed by clinical examination and brain MRI...
- A history of other malignant tumors within 2 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the lung, breast, or other sites, or other tumors whose related treatments will...
- A history of severe cardiovascular and cerebrovascular diseases.
- Has received anti-tumor therapies including locoregional radiotherapy, chemotherapy, immunotherapy, or targeted therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; for treatment with...
- Has received major surgery other than diagnostic procedures or locoregional therapy targeting liver lesions within 4 weeks prior to the first dose.
- Has received investigational drugs in other clinical trials within 4 weeks prior to the first dose.
- All toxicities from prior anti-cancer therapies must have resolved to ≤ grade 1 at the start of study drug administration.
- Moderate to large symptomatic pleural effusion, pericardial effusion, or ascites requiring thoracentesis/paracentesis or with a history of thoracentesis/paracentesis within 2 weeks prior to the start of study treatment...
- Need for concomitant use of strong CYP3A4 inhibitors or inducers during the study period.
- Any severe acute or chronic infections requiring systemic antibiotic or antiviral therapy at screening.
- Known human immunodeficiency virus (HIV) infection or positive syphilis test result.
- Pregnant, lactating, or women planning to become pregnant.
- Concomitant diseases that may interfere with the conduct of the study, or physical abnormalities that the investigator deems pose an excessive risk to the subject, including but not limited to a history of significant...
- A history of hypersensitivity to ethanol or propylene glycol.
- Other reasons judged by the investigator that make the subject unsuitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. 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.