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Tests treatment safety and results for Carcinoma, Hepatocellular
Official title A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07010497
What this study is testing
What is irpagratinib?
irpagratinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for carcinoma, hepatocellular.
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 phase 2, open-label study to evaluate the safety, tolerability and efficacy of Irpagratinib in combination with Atezolizumab and Bevacizumab in patients with advanced or unresectable HCC harboring FGF19 overexpression. This study composes two parts, a Safety Run-in part to evaluate safety and establish the dose of Irpagratinib for the triple combination, and an Expansion part to evaluate the preliminary efficacy and safety using Simon's two-stage design.
- 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 19 and older
You may be able to join if
- 1.Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient...
- 2.Male or female, aged ≥19 at the time of signing inform consent form.
- 3.Patients must have histological or cytological confirmed advanced or unresectable HCC not amenable to curative surgical or loco-regional therapies...
- Provide archived tissue sample for FGF19 overexpression detection.For Safety-Run in and Expansion: the result of FGF19 overexpression lab testing...
- Barcelona Clinic Liver Cancer (BCLC) stage B or C and Child-Pugh score 5\~6 without hepatic encephalopathy, no clinically apparent ascites or require...
You likely can't join if
- Prior/Concomitant Therapy
- 1\. Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable...
- 2\. Has received prior therapy with immune checkpoint inhibitors or immune stimulatory agents (eg, anti-PD-1, anti-PD-L1/2, anti-CTLA-4, anti-TIGIT...
- 3\. Previous treatment with FGFR inhibitors including selective FGFR4 or pan-FGFR inhibitors.
- 4\. Has received locoregional therapy to liver (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiation...
- 5\. Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow...
See the full eligibility criteria
Who can join
- 1.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...
- 2.Male or female, aged ≥19 at the time of signing inform consent form.
- 3.Patients must have histological or cytological confirmed advanced or unresectable HCC not amenable to curative surgical or loco-regional therapies. And patients must satisfy:
- Provide archived tissue sample for FGF19 overexpression detection.For Safety-Run in and Expansion: the result of FGF19 overexpression lab testing must be positive as defined. Only tissue from primary lesion of liver is...
- Barcelona Clinic Liver Cancer (BCLC) stage B or C and Child-Pugh score 5\~6 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention.
- Have at least 1 target lesion (per RECIST v1.1). Patients who received prior local therapy (e.g., radiofrequency ablation, percutaneous injection, cryoablation, high-intensity focused ultrasound, transarterial (chemo)...
- 4.ECOG performance status score 0-1
- 5.Life expectancy ≥ 3 months
- 6.Adequate organ and hematologic function as indicated by the following screening assessments performed within 14 days prior to the first administration (without blood transfusion, or medication with stimulation factors...
- 7.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...
What rules you out
- Prior/Concomitant Therapy
- 1\. Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC. Patient who has received one cycle of Atezolizumab plus...
- 2\. Has received prior therapy with immune checkpoint inhibitors or immune stimulatory agents (eg, anti-PD-1, anti-PD-L1/2, anti-CTLA-4, anti-TIGIT, OX-40, or CD137). Patients has received one cycle of Atezolizumab plus...
- 3\. Previous treatment with FGFR inhibitors including selective FGFR4 or pan-FGFR inhibitors.
- 4\. Has received locoregional therapy to liver (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiation, radioembolization, or ablation) within 4 weeks prior to the first dose...
- 5\. Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure \>30%), loco-regional treatment \<4 weeks; endocrine therapy with...
- 6\. Prior toxicities from radiotherapy and other anti-cancer therapies that have not recovered to Grade ≤1 (CTCAE v5.0) except for which eligibility criteria allowed, alopecia, vitiligo, hormone replacement therapy...
- 7\. Concomitant use of P-gp transporter inhibitors; as well as moderate or strong inhibitors or inducers of CYP3A4 (including grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, Seville oranges or...
- 8\. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and...
- 9\. Vaccination with a live, attenuated vaccine within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated...
- 10\. Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDS for the symptomatic relief of medical conditions such as headache or fever is allowed.
- 11\. Active infection or unexplained fever \> 38.5℃ or last treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to the first dose of study treatment. Factors related to the disease
- 12\. Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.
- 13\. Has a known active central nervous system (CNS) metastasis.
- 14\. Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses (\<30 mm from the carina) of large volume. Patients with vascular invasion of the portal or hepatic...
- 15\. Patients with refractory/uncontrolled ascites, pleural effusion or pericardial effusion requiring intervention within 2 weeks before administration of study treatment.
- 16\. History of hepatic encephalopathy.
- 17\. Liver tumor as a percentage of liver ≥ 50% as judged by the investigator.
- 18\. Vp4 type portal vein tumor thrombus and beyond (such as inferior vena cava).
- 19\. Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding or a prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of...
- 20\. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of Bevacizumab.
- 21\. History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment. Diagnostic Assessments
- 22\. History of second primary malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the...
- 23\. Known allergy or hypersensitivity to any component of the investigational drug product formulation or history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. Known...
- 24\. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- 25\. Prolongation of QTcF (\> 470 ms [average of three ECGs], QTc interval corrected by Frederica's formula, QTcF=QT/RR0.33) at screening, and other ECG abnormalities with clinical significance by the judge of the...
- 26\. Left ventricle ejection fraction\<50%.
- 27\. Impaired cardiac function or clinically significant cardiac disease, including but not limit to any one of the following: New York Heart Association class III or IV congestive heart failure, unstable angina, or...
- 28\. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to initiation of study treatment.
- 29\. Any serious acute or chronic infection requiring systemic anti-infective therapy (except for viral hepatitis, see exclusion criteria 31-33).
- 30\. History of immunodeficiency, including HIV antibody serum test positive, or other acquired/congenital immunodeficiency disease, or active tuberculosis.
- 31\. Patients with HBV infection should follow local clinical practice and anti-HBV therapy should be performed to ensure adequate viral suppression. HBV-DNA ≥2000 IU/mL (or equivalent copies/mL) obtained within 14 days...
- 32\. Patients with HBV and HCV co-infection. If there is only a history of HCV infection, but HCV RNA (-), it is not regarded as HCV infection.
- 33\. Patients with active HCV infection (HCV-RNA\>103 copies/mL or following local clinical practice) or require concomitant anti-HCV therapy during the study.
- 34\. 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...
- 35\. History of allogeneic stem cell transplantation or organ transplantation.
- 36\. History of hemoptysis (≥2.5mL of bright red blood per episode) within 1 month prior to initiation of study treatment.
- 37\. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- 38\. Current or recent (within 10 days prior to study treatment start) use of aspirin (\>325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
- 39\. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anti-coagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose.
- 40\. Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR\<1.5×ULN and APTT is within normal limits within 14 days prior to initiation of...
- 41\. For prophylactic use of anti-coagulants or thrombolytic therapies, local label approved dose levels may be used.
- 42\. Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture.
- 43\. 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...
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. 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.