CTRI/2019/04/018775尚未招募2 期
A Phase 1b/2 Open-label Study with randomization in Phase 2 of IMU-131 HER2/neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients with HER2/neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction. - IMU-131
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
入选标准
- •1. Patient has been informed of the investigational nature of this study and has given
- •written informed consent in accordance with institutional local and national
- •2. Age more than and equal to 20 years old
- •3. Life expectancy of at least 12 weeks
- •4. No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 3 months prior to Day 0
- •5. Metastatic gastric or GEJ adenocarcinoma or locally advanced disease not amenable to surgical resection
- •6. HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+
- •confirmed by fluorescent in situ hybridization FISH] or chromogenic in situ hybridization [CISH]). Patients with IHC 2+ expression without confirmation of overexpression by fluorescent in situ hybridization [FISH] or chromogenic in situ
- •hybridization [CISH]) may be included in Phase 1b with agreement of Imugene Limited
- •7. ECOG performance status 0â??2
- •8. At least one measurable lesion as defined by RECIST 1.1 criteria. Patients with non-measurable lesions may be included in Phase1b with agreement of Imugene Limited
- •9. Adequate left ventricular ejection function at baseline defined as LVEF > 50% by echocardiogram or MUGA scan (Multi Gated Acquisition Scan)
- •10. Adequate hematologic function absolute neutrophil count (ANC) >= 1.5 x 109/L, platelet count >= 100 x 109/L, and hemoglobin >= 9 g/dL;
- •11. Adequate liver function evidenced by bilirubin <= 1.5 x laboratory upper limit of
- •normal [ULN] and ALT and AST <= 3 x laboratory ULN if no liver involvement or ALT and AST <= 5 times laboratory ULN with liver involvement
- •12. Adequate renal function (creatinine <= 1.5 x laboratory ULN
- •13. Willing and able to comply with scheduled visits treatment plan laboratory tests and other study procedures
- •14. Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment . A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
排除标准
- •1. Previous treatment with trastuzumab or any other HER2/neu targeting antibody or
- •2. Continuous systemic treatment with either corticosteroids (Greater than 10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in
- •the absence of active auto-immune disease
- •3. Prior organ transplant
- •4. Patient not considered a candidate for 5-FU, capecitabine,cisplatin or
- •oxaliplatin chemotherapy;
- •5. History of documented congestive heart failure; angina pectoris requiring
- •antianginal medication; evidence of transmural infarction on ECG; poorly
- •controlled hypertension; clinically significant valvular heart disease; high risk
- •uncontrolled arrhythmias; or New York Heart Association (NYHA) class II heart
- •6. If on warfarin (Coumadin®) or other vitamin K antagonists;
- •7. Concurrent active malignancy except for adequately controlled limited basal cell
- •carcinoma of the skin
- •8. Peripheral neuropathy or hearing loss of NCI CTCAE Grade greater than and equal to 2
- •9. History of uncontrolled seizures, central nervous disorders or psychiatric disability
- •judged by the investigator to be clinically significant and precluding informed
- •consent, participation in the study, or adversely affecting compliance to study
- •10. Active infection requiring IV antibiotics;
- •11. Positive for human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or active
- •hepatitis B (HBsAg reactive) or active hepatitis C (HCV ribonucleic acid [RNA]
- •qualitative) infection;
- •12. Pregnant or lactating females;
- •13. Major surgery within 4 weeks prior to study entry. Minor surgery (excluding
- •diagnostic biopsy) within 1 week prior to study entry;
- •14. Has received a live-virus vaccination within 4 weeks of first study vaccination.
- •Seasonal flu vaccines that do not contain live virus are permitted;
- •15. Current or recent (within 4 weeks of first IMU-131 vaccination) treatment with
- •another investigational drug or participation in another investigational study.
- •16. Phase 2: Patients with a known diphtheria toxoid hypersensitivity.
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