EUCTR2021-003189-11-IT招募中1 期
An open label study followed by a randomised, double-blind, placebo-controlled, parallel group and an extension study to investigate the safety and efficacy of GB1211 (a galectin-3 inhibitor) in combination with atezolizumab in patients with Non-Small Cell Lung Cancer (NSCLC). - GALLANT-1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 77
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
- 性别
- All
入选标准
- •1. Must be = 18 years of age at the time of signing the Informed Consent Form (ICF).
- •2. Must provide signed ICF.
- •3. Must have the ability to comply with the study protocol, in the investigator’s judgment.
- •4. Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agree to refrain from donating eggs.
- •5. Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agree to refrain from donating sperm.
- •6. Diagnosed NSCLC with adenocarcinoma and its variants according to the 2015 WHO classification.
- •7. Measurable disease, as defined by RECIST v1.1.
- •8. Have histologically or cytologically confirmed advanced or metastatic NSCLC defined as: Stage IIIB that either progressed after curative therapy or is not candidate to curative therapy, or Stage IV metastatic disease.
- •9. Expressing PD-L1 on at least 50% of tumour cells.
- •10. Agree to have a tumour biopsy that is eligible for Gal-3 expression evaluation before the first study drug dose.
- •11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •12. Have not received prior systemic chemotherapy for the treatment of recurrent, advanced or metastatic disease, treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 4 weeks prior to diagnosis of recurrent advanced or metastatic disease.
- •13. Patients must not have received immune checkpoint inhibitors previously.
- •14. Must be eligible for atezolizumab at 1200 mg every 3 weeks as defined in the atezolizumab product label.
- •15. Patients receiving therapeutic anticoagulation must be on stable regimen.
- •16. Adequate haematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- •Absolute neutrophil count (ANC) = 1.5 × 109/L (1500/µL) without granulocyte colony-stimulating factor support.
- •Lymphocyte count = 0.5 × 109/L (500/µL).
- •Platelet count = 100 × 109/L (100,000/µL) without transfusion.
- •Haemoglobin = 90 g/L (9 g/dL). Patients may be transfused to meet this criterion.
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 2.5 × upper limit of normal (ULN), with the following exceptions:
- •o Patients with documented liver metastases: AST and ALT = 5 × ULN.
- •o Patients with documented liver or bone metastases: ALP = 5 × ULN.
- •Total bilirubin = 1.5 × ULN with the following exception:
- •Patients with known Gilbert disease: total bilirubin = 3 × ULN.
- •Creatinine clearance = 50 mL/min (calculated using the Cockcroft-Gault formula).
- •Albumin = 25 g/L (2.5 g/dL).
- •For patients not receiving therapeutic anticoagulation: INR and a PTT = 1.5 × ULN.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •2. Patients with known hypersensitivity to GB1211 or any of the excipients.
- •6. Life expectancy = 12 weeks.
- •9. Diagnosed NSCLC with squamous cell carcinoma.
- •16. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.
- •18. Patients with acute neurological events (e.g., intracranial or subarachnoid haemorrhage, stroke, intracranial trauma) within 6 months of inclusion.
- •19. Patients with symptomatic, untreated, or actively progressing central nervous system (CNS) metastases confirmed by a CT or MRI scan.
- •21. History of malignancy other than NSCLC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate = 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
- •22. Patients with past medical history or any evidence of clinically active interstitial lung disease, including drug-induced interstitial lung disease.
- •23. Uncontrolled significant pleural effusion.
- •24. History of non-infectious pneumonitis that required steroids or current pneumonitis.
- •26. Patients with a history of arrhythmia, especially ventricular arrhythmias, atrial fibrillation or recent recovery of rhythm after atrial fibrillation.
- •27. Patients with bradycardia (<50 beats per minute).
- •28. Patients with left ventricular ejection fraction (LVEF) of =40%.
- •29. Patients with a family history of sudden cardiac death before the age of 50.
- •30. Patients with a QT/QTc interval > 470 ms (for women) and > 450 ms (for men) at screening or congenital long QT syndrome.
- •31. Patients with electrolyte imbalances: hypokalaemia, hypomagnesemia, or hypocalcaemia.
- •32. Patients with history of organ transplant or hematopoietic stem cell transplantation.
- •36. Patients who have received GB1211 prior to this study.
- •38. Surgery within 3 weeks before the study.
- •42. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment.
- •43. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor-a [TNF-a] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.
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