NL-OMON56720尚未招募不适用
A phase I/IIa open label study to assess the safety, tolerability, immunogenicity and clinical activity of EI-201 mRNA immunotherapy given intravenously in subjects with recurrent or metastatic HPV16 positive carcinoma - E012-HPV
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria to be assessed at Screening:
- •1. Age greater than or equal to 18 years.
- •2. Cohort 1: Confirmed recurrent and/or metastatic (R/M) HPV16+ cancer
- •(including oropharyngeal, cervical, vulvar, vaginal, anal, penile cancer) based
- •on expression analysis of HPV type 16 in tumor tissue by HPV 16 ISH or HPV E1
- •PCR. Cancer must have progressed after at least 1 available standard therapy
- •for incurable disease, or the subject is intolerant to or refuses standard
- •therapy(ies) or has a tumor for which no standard therapy(ies) exists.
- •Cohort 2: Confirmed R/M HPV16+ oropharyngeal cancer (based on expression of HPV
- •type 16 in tumor tissue by HPV 16 ISH or HPV E1 PCR), and eligible for 1st line
- •monotherapy pembrolizumab treatment OR
- •subjects with confirmed incurable R/M anogenital HPV16+ cancer (cervical, anal,
- •penile, vulvar, or vaginal cancer) confirmed by HPV 16 ISH or HPV E1 PCR.
- •Maximum 2 previous systemic therapies with chemotherapy and/or targeted
- •therapies for recurrent and/or metastatic disease, no prior aPD(L)-1, and a
- •3. Life expectancy of at least 12 weeks.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •5. At least one measurable lesion, as defined by Response Evaluation Criteria
- •in Solid Tumors version 1.1 (RECIST 1.1; Eisenhauer et al, 2009).
- •6. Willing and able to give written informed consent.
- •7. Willing and able to attend the scheduled study visits and to comply with the
- •study procedures, treatment schedule, laboratory test and other requirements of
- •8. Subjects entering the study will need to consent to provide a tumor tissue
- •sample (formalin fixed paraffin embedded blocks/slides less than 2 months old
- •or older only upon approval by Sponsor) or a fresh biopsy before the first dose
- •of the study treatment and a mandatory biopsy at Week 6 (Cohort 1) or Week 9
- •(Cohort 2) post start of treatment. Biopsy should be excisional, incisional or
- •core needle. Fine needle aspiration is insufficient.
- •9. Adequate hematologic function with:
- •a) white blood cell (WBC) count >= 3,000 mm³
- •b) hemoglobin >= 9 g/dL
- •c) platelets >= 75,000/mm³
- •d) lymphocyte count >=500 cells/mm3
- •10. Adequate renal and hepatic function with:
- •a) serum creatinine <= 1.5 x upper limit of normal (ULN) or creatinine-clearance
- •>= 40 mL/minute using the Cockcroft-Gault formula
- •b) alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino
- •transferase (AST) <= 1.5 x ULN (subjects with liver metastasis can have up to 5
- •c) bilirubin < 2.0 mg/dL (except for subjects with Gilbert*s disease)
- •11. Adequate coagulation parameters with:
- •a) Prothrombin international normalized ratio (INR) < 1.5
- •b) Partial thromboplastin time < 1.5 x ULN
- •12. Men who are sexually active with WOCBP must agree to use any contraceptive
- •method with a failure rate of less than 1% per year. The Investigator shall
- •review contraception methods and the time period that contraception must be
- •13. A female subject is eligible to participate if she is not pregnant, not
- •breastfeeding, and at least one of the following conditions applies:
- •a) Not a woman of childbearing potential (WOCBP)
- •b) A WOCBP (defined as < 2 years after last menstruation or not surgically
- •sterile) must have a negative highly sensitive pregnancy test at screening
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排除标准
- •Exclusion criteria to be assessed at Screening:
- •1. Subjects treated with any investigational agent within the past 4 weeks
- •before the start of therapy are excluded.
- •2. Grade 3 or 4 peripheral neuropathy at time of screening.
- •3. Subjects with active or history of autoimmune disease or immune deficiency
- •such as, but not restricted to, myasthenia gravis, antiphospholipid antibody
- •syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome,
- •inflammatory bowel disease, systemic lupus erythematosus, ankylosing
- •spondylitis, scleroderma, rheumatoid arthritis or multiple sclerosis, with the
- •following exceptions:
- •- endocrine autoimmune disorders (i.e., autoimmune hypothyroidism who are on
- •thyroid replacement hormone, type 1 diabetes, Addison*s disease, etc.)
- •- controlled eczema, psoriasis, lichen simples or vitiligo with dermatological
- •manifestations only
- •- rash < 10% of body surface area.
- •4. Subjects with serious intercurrent chronic or acute illness such as
- •pulmonary [severe asthma or chronic obstructive pulmonary disease (COPD)],
- •cardiac (New York Heart Association [NYHA] class III or IV), hepatic disease,
- •renal insufficiency or other illness considered by the Investigator to
- •constitute an unwarranted high risk for investigational drug treatment.
- •5. Subjects with known history of allergic reactions to contrast.
- •6. Subjects with significant psychiatric disabilities or seizure disorders.
- •7. Legal incapacity or limited legal capacity.
- •8. Subjects who have had a splenectomy.
- •9. Subjects with known hypersensitivity to any component of the Investigational
- •Medicinal Product and/or pembrolizumab (Cohort 2).
- •10. Prior treatment with therapeutic HPV vaccines. Subjects may have received a
- •preventive HPV vaccine.
- •11. Subjects who received an mRNA LNP based vaccine less than 30 days prior to
- •start of the therapy.
- •12. Concurrent second malignancy other than non-melanoma skin cancer or
- •controlled superficial bladder cancer. In the event of prior malignancies
- •treated surgically, the subject must be considered NED (no evidence of disease)
- •for a minimum of 3 years prior to enrollment.
- •13. Subjects on corticosteroid therapy > 10 mg prednisone (or equivalent) or
- •other immunosuppressive agents such as azathioprine or cyclosporine A (but not
- •limited to these) are excluded on the basis of potential immune suppression.
- •14. Presence of an active acute or chronic infection, including symptomatic
- •urinary tract infection, human immunodeficiency virus (as determined by enzyme
- •linked immunosorbent assay and confirmed by Western Blot) or viral hepatitis
- •(as determined by hepatitis B antigen and hepatitis C serology).
- •15. Subject is pregnant, intending to become pregnant or is currently
- •breast-feeding.
- •16. Subject testing positive for SARS-CoV-2 infection as detected by nasal real
- •time polymerase chain reaction (RT-PCR) or subjects who have been in contact
- •with SARS-CoV-2 infected individuals in the 2 weeks prior to first dosing of
- •IMP. Subjects presenting any signs or symptoms of SARS-CoV-2 infection as
- •detected at screening and/or baseline following careful physical examination
- •(e.g., cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia,
- •anorexia, sore throat, etc.) will also be excluded. In addition, any other
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