EUCTR2018-000995-14-ES进行中（未招募）1 期
A Phase 1/2a Study in 3 Parts (Phase 1a and Phase 1b - Dose Escalations and Phase 2a Expansion Cohorts) to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MIV-818 in Patients with Liver Cancer Manifestations
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Medivir AB
- 入组人数
- 102
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
- •Unless otherwise stated, inclusion criteria apply to all phases and cohorts in the study.
- •1. Male or female = 18 years of age on the day of signing informed consent.
- •2. Signed informed consent and is willing, and able, to comply with the protocol requirements.
- •3. Must have measurable disease based on RECIST v1.1 as determined by the site study team. Must have at least 1 target lesion in the liver. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Patients who have had previous loco-regional therapy (e.g. RFA or TACE) will be eligible but should have either a new lesion or the treated lesion should show evidence of progressive disease that can be measured (e.g. for HCC a new area of enhancement with washout on liver triple phase CT).
- •4.Must have a Child-Pugh A status for Phase 1a and combination therapy parts but may have Child-Pugh A or B status for Phase 1b monotherapy. Based on review of data, the SRC has discretion to restrict to Child-Pugh A status for Phase 1b monotherapy.
- •5. Must have an ECOG performance status of 0 or 1 at Screening.
- •6. Must have life expectancy of > 12 weeks in the investigator’s opinion.
- •7. Must have ALT and AST = 5.0 × upper limit of normal (ULN) at Screening.
- •8. Must have total bilirubin (TBil) = 3.0 mg/dL or = 51.3 µmol/L at Screening.
- •9. Must have adequate renal function with estimated creatinine clearance = 60 mL/min (based on Cockcroft and Gault formula or similar) at Screening
- •10. Must have platelets = 75,000/µL at Screening.
- •11. Must have International Normalized Ratio (INR) = 1.7 at Screening.
- •12. Female who is postmenopausal,
- •Female who is of childbearing potential (postmenarchal) who agrees to use a highly efficient method of contraception (ie, a method with less than 1% failure rate [eg, sterilization, hormone implants, hormone injections, intrauterine devices, or vasectomized partner or combined birth control pills]) from Screening until 90 days after the final dose of MIV-818.
- •Male who agrees to use condoms from Screening until 90 days after the final dose of MIV-818.
- •Male with a female partner of childbearing potential (WOCBP) who is using a highly efficient method of contraception as described above.
- •13. WOCBP must have a negative serum pregnancy test at Screening and negative (serum or urine) pregnancy test within 72 h before the first study drug dose. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.
- •Phase 1a specific Inclusion Criteria:
- •14. Must have progressed on or are intolerant of standard therapy with:
- •a. Histologically or cytologically confirmed HCC, including fibrolamellar HCC; patients with HCC that received their diagnosis according to the agreed international radiological guideline are also admissible upon agreement between the investigator and the medical monitor, or
- •b. Histologically or cytologically confirmed iCCA, or
- •c. Liver metastases from colon, rectal or gastric solid tumors, with limited extrahepatic tumor burden. (any extrahepatic metastases should be limited to 1 other site and a maximum of 1 target lesion outside the liver).
- •Phase 1b Monotherapy-specific Inclusion Criterion:
- •15. Must have:
- •o Histologically or cytologically confirmed HCC including fibrolamellar HCC; patients with HCC that received their diagnosis accordin
排除标准
- •Patients are excluded from this study if any 1 or more of the following criteria is met:
- •1. Tumor volume exceeding 50% of liver.
- •2. History of previous malignancy within the last 2 years except basal cell carcinoma or carcinoma in situ in solid organ.
- •3. Known CNS or brain metastases, unless previously treated and stable for 3 months.
- •4. Ongoing significant disease other than target disease as judged by the investigator to compromise the patients’ ability to complete this study.
- •5. History of solid organ transplant or bone marrow transplant.
- •6. Receiving immunosuppressive therapy including oral corticosteroids exceeding 15 mg daily of prednisone, 2 mg daily of dexamethasone or equivalent.
- •7. Active hepatitis B defined as acute hepatitis B infection or reactivation of chronic hepatitis B e.g., hepatitis B surface antigen [HBsAg] reactive and patients with active hepatitis C (e.g., hepatitis C RNA is [quantitatively] detected) with a viral load >800,000 IU/mL.
- •8. Positive human immunodeficiency virus (HIV) infection.
- •9. Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
- •10. Symptomatic encephalopathy within 3 months prior to Screening and/or requirement for medication for encephalopathy.
- •11. Esophageal variceal bleeding within 2 weeks (12 weeks if receiving lenvatinib) prior to Screening.
- •12. Receiving anticancer therapy within 4 weeks prior to first dose of MIV-818.
- •13. Receiving any other investigational agent within 4 weeks prior to Screening
- •14. Enrolled in another clinical study with an investigational drug.
- •15. Presence of residual toxicities of CTCAE Grade > 1 after prior anticancer therapy within 2 weeks of first treatment with MIV-818, except for alopecia.
- •16. History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biological composition to MIV-818 (applicable to both phases), lenvatinib, pembrolizumab, or their excipients (applicable to Phase 1b combination part only).
- •17. HCC of diffuse infiltrative type.
- •18. Receiving drugs that are extensively metabolized by cytochrome P450 (CYP) 3A4. Drugs that are extensively metabolized by CYP3A4 must be discontinued 5 half-lives before first dose of MIV-818.
- •Combination therapy specific Exclusion Criteria
- •Patients are excluded from the combination therapy parts of this study if any of the following criteria are met:
- •19. Patients with a diagnosis of fibrolamellar HCC.
- •20. Received =2 lines of therapy for the treatment of advanced HCC
- •21. Systolic blood pressure (BP) =160 mmHg or diastolic BP =100 mmHg despite optimal anti-hypertensive therapy and with no change in anti-hypertensive agents within the last 1 week prior to Screening.
- •22. Proteinuria > 1g / 24 h.
- •23. Bleeding disorders, on anti-coagulation drugs or anti-platelet therapies.
- •24. Any interventional treatment for esophageal varices required within 28 days of study treatment
- •25. Hepatic encephalopathy in the last 6 months.
- •26. QTc interval is greater than 480 ms at Screening.
- •27. Active autoimmune disease that has required systemic treatment in
- •the past 2 years. Replacement therapy
- •(e.g., thyroxine, insulin, or physiologic corticosteroid replacement
- •therapy for adrenal or pituitary insufficiency, etc.) is not considered a
- •form of systemic treatment.
- •28. Has an active infection requiring systemic therapy. Exclusion criteria
- •applicable to pembrolizumab cohort only
- •29. Diagnosis of immunodeficiency or is receiving chronic sys
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