EUCTR2016-003543-11-FR进行中（未招募）1 期
A Phase 1/2, open-label, multicenter, dose escalation and dose expansion study of NKTR-214 and Nivolumab in patients with select locally advanced or metastatic solid tumor malignancies
ektar Therapeutics0 个研究点目标入组 290 人开始时间: 2017年11月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 290
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
- •For Dose Escalation (Part 1) and Dose Expansion (Part 2):
- •1. Willing and able to provide written informed consent
- •2. Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC
- •3. Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF)
- •4. Life expectancy >12 weeks
- •5. Patients must not have received prior interleukin 2 (IL 2) therapy
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •7. Measurable disease per RECIST 1.1
- •8. Demonstrated adequate organ function, as defined below, within 14 days of treatment initiation
- •a. White blood cell (WBC) count = 2000/µL (after at least 7 days without growth factor support or transfusion)
- •b. Absolute neutrophil count (ANC) = 1500/µL (after at least 7 days without growth factor support or transfusion)
- •c. Platelet count = 100 × 103/µL (transfusions allowed)
- •d. Hemoglobin = 9.0 g/dL (transfusions allowed)
- •e. Serum creatinine = 2 mg/dL (or glomerular filtration rate = 40 mL/min)
- •f. Aspartate aminotransferase (AST) and alanine transaminase (ALT) = 3× upper limit of normal (ULN)
- •g. Total bilirubin within normal limits unless associated with hepatobiliary metastases or Gilbert’s syndrome, in that case total bilirubin = 2× ULN
- •h. Lipase and amylase = 1.5× ULN. Patients with pancreatic metastases and lipase and/or amylase < 3× ULN may enroll. Patients may not enroll if there are clinical or radiographic signs of pancreatitis.
- •9. On stress echocardiogram, documented left ventricular ejection fraction > 45% on cardiac stress test within 60 days prior to Cycle 1 Day 1. At the discretion of the Investigator, patients who are unable to perform a stress echocardiogram may instead have a multigated acquisition (MUGA) scan or transthoracic echocardiogram (TTE).
- •10. Oxygen saturation = 92% on room air
- •11. Clinically significant toxic effect(s) of the most recent prior chemotherapy must be resolved to Grade 1 or less (except alopecia and sensory neuropathy). If the patient received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
- •12. Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug. Acceptable methods are defined as those that result, alone or in combination, in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, or hormonal contraception in combination with a barrier method. It is currently unknown whether NKTR-214 may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a barrier method. In certain countries (if permitted by law), WCBP may agree to abide by heterosexual sexual abstinence during the time of participation in this study.
- •13. Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing u
排除标准
- •1. Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug
- •2. Females who are pregnant or breastfeeding
- •3. Patients who have an active, known or suspected autoimmune disease. Patients requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves’ disease, Hashimoto's disease, alopecia areata, eczema, or with Medical Monitor approval)
- •4. History of allergy or hypersensitivity to study drug components
- •5. Active malignancy not related to the current diagnosed malignancy
- •6. History of organ transplant that requires use of immune suppressive agents
- •7. Use of warfarin within 14 days of initiating study drug (Note: Low molecular weight heparin is allowed on the study)
- •8. Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis
- •9. Prior surgery or radiotherapy within 14 days of therapy. Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis.
- •10. Patients who have had < 28 days since the last chemotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobimetinib), or systemic or inhaled steroid therapy at doses greater than 10 mg of prednisone or equivalent before administration of the first dose of study drug.
- •11. Patients in whom prior checkpoint inhibitor therapy was intolerable and required discontinuation of treatment
- •12. NSCLC patients who require supplemental oxygen
- •13. Active infection requiring systemic therapy
- •14. Has known hepatitis B virus (HBV) infection (e.g., HBsAg reactive) or hepatitis C virus (HCV) infection (e.g., HCV RNA qualitative is detected)
- •15. Has known immunodeficiency or active human immunodeficiency virus (HIV 1/2 antibodies)
- •16. Prolonged QTcF > 450 ms for men and > 470 ms for women at Screening
- •17. History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
- •a. Unstable angina or myocardial infarction
- •b. Congestive heart failure (New York Heart Association [NYHA] Class III or IV)
- •c. Uncontrolled clinically significant arrhythmias
- •18. Need for > 2 antihypertensive medications for management of hypertension (including diuretics)
- •19. Known current drug or alcohol abuse
- •20. Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator, would preclude the patient from adhering to the protocol
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