EUCTR2021-005431-23-NL进行中（未招募）1 期
AN OPEN LABEL, RANDOMISED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MTL-CEBPA ADMINISTERED IN COMBINATION WITH SORAFENIB OR SORAFENIB ALONE, IN TKI NAÏVE PARTICIPANTS WITH PREVIOUSLY TREATED ADVANCED HEPATOCELLULAR CARCINOMA (HCC) AND HEPATITIS B OR HEPATITIS C VIRUS (OUTREACH2) - Safety, tolerability, and efficacy of MTL-CEBPA plus sorafenib in HCC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent obtained prior to any specific trial-related procedure
- •2. Male or female 18 years or older.
- •3. Histologically confirmed advanced HCC with cirrhosis in a participant with a history of hepatitis B and/or C. Participants with past or ongoing HCV infection will beeligible for the study. Participants must have completed their treatment at least 1 month prior to starting study intervention and their HCV viral load below the limit ofquantification. Participants who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution will be eligible. Participants with past or controlled ongoing hepatitis B will be eligible as long as their HBV viral load is less than 500 IU/mL prior to first dose of study drug. Participants on active HBV
- •therapy with viral loads under 100 IU/mL should stay on the same therapy throughout study intervention.
- •4. Child-Pugh classification A.
- •5. Unsuitable for liver tumour resection and/or refractory to loco regional therapy.
- •6. Not eligible for liver transplantation.
- •7. Had progression or recurrence of HCC following previous treatment with atezolizumab in combination with bevacizumab. Participants with progression or recurrence of HCC on non atezolizumab anti-PD-1/PD-L1 inhibitors and non-bevacizumab anti-VEGF agent in combination or as any as single agents, and no priortreatment with atezolizumab and bevacizumab, are eligible.
- •8. Naïve to tyrosine kinase inhibitors, including sorafenib, regorafenib, cabozantinib, and lenvatinib.
- •9. Participants with BCLC stage C disease.
- •10. Eastern Cooperative Oncology Group performance status of 0 or 1.
- •11. Has the ability to swallow and retain oral medication.
- •12. Life expectancy greater than 3 months at time of recruitment.
- •13. At least one measurable liver lesion (RECIST v1.1) assessed by the investigator.
- •14. Platelet count >70 x 109/L.
- •15. Serum albumin =28 g/L.
- •16. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =5 x the upper limit of normal (ULN).
- •17. Bilirubin =50 µmol /L.
- •18. White Blood Cell (WBC) =2.0 x 109/L.
- •19. Absolute neutrophil count =1.5 x 109/L.
- •20. Haemoglobin =9.0 g/dL.
- •21. International Normalized Ratio (INR) <1.5.
- •22. Calculated creatinine clearance =50 mL/min (Cockcroft & Gault).
- •23. AEs due to prior therapy must have resolved to Grade =1
- •24. Negative blood pregnancy test for women of childbearing potential (within 10 days prior to first drug administration).
- •Note: a woman is considered of child-bearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent methods ofsterilisation include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without analternative medical cause.
- •Female participants of childbearing potential must use highly effective* contraceptive measures adequate to prevent a new pregnancy for the duration of the studytreatment with MTL-CEBPA and sorafenib and, in addition, for at least six months after the last dose of MTL-CEBPA and six months beyond the last dose of sorafenib, as recommended in sorafenib’s U.S. Package Insert (USPI). For women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended.
- •25. Male participants with partners of child-bearing potential must use highly effective contraception and are required to use barrier contraception plus an additionalcontraceptiv
排除标准
- •1. Child-Pugh classification B and C.
- •2. Participants without a history of hepatitis B and/or hepatitis C.
- •3. Participants with fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtype HCC.
- •4. Participants with no prior therapy who are eligible for first-line treatment with atezolizumab in combination with bevacizumab.
- •5. Participants who received investigational drug(s) within the last 30 days prior to study treatment initiation.
- •6. Participants with clinically significant ascites.
- •7. Any episode of bleeding from oesophageal varices or other uncontrolled bleeding including clinically meaningful epistaxis within the last 3 months prior to study treatment initiation.
- •8. Clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy.
- •9. Participants with a history of gastrointestinal haemorrhage or perforation.
- •10. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated such metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging performed during study screening, clinically stable and without requirement of steroid treatment for at least 28 days prior to first dose of study intervention. MRI brain scan are required for all participants with stable brain metastases at screening (CT scan will be allowed if MRI is contraindicated).
- •11. Participants administered with serum albumin within the last 7 days prior to the first study treatment administration.
- •12. Known infection with human immunodeficiency virus (HIV) with CD4+ T-cell counts <350 cells/µL or with a history of AIDS-defining opportunistic infection. NoHIV testing is required unless mandated by local health authority.
- •13. Received a live vaccine within 30 days prior to the first dose of study treatment. Live vaccines include, but are not limited to: measles, mumps, rubella,
- •varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- •14. Known other malignancy that is progressing or has required active treatment in the last 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death such as early-stage cancers treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
- •15. Participants presenting with a baseline prolongation of QT/QTc interval defined as repeated demonstration of a QTc interval =450 ms (males) and =460 ms (females) using Fridericia’s correction formula.
- •16. Participants with a screening diastolic blood pressure >90 mm Hg.
- •17. Clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
- •Note: Medically controlled arrhythmia would be permitted.
- •18. Major surgery within the last 30 days prior to study treatment initiation. If the participant had major surgery, the participant must have recovered adequately fromthe procedure and/or any complications from the surgery prior to starting study interve
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