EUCTR2021-001530-19-DE进行中（未招募）1 期
An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects with Relapsed or Refractory Small Cell Lung Cancer (SCLC) - INDEPENDENCE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- •1. Subjects =18 years of age and able to provide informed consent
- •2. Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT.
- •3. Disease must be measurable, with at least 1 measurable lesion per RECIST Version 1.1 (Appendix 4)
- •4. Subjects have evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.
- •5. Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.
- •6. Adequate hematologic function independent of growth factor support for at least 7 days with the exception of pegylated granulocyte-colony stimulating factor (G-CSF) which require at least 14 days, defined as:
- •a. ANC = 1.0 x 109/L
- •b. Platelet count =100 x 109/L
- •7. Adequate hepatic function with 28 days prior to the first dose of study treatment defined as:
- •a. Total serum bilirubin within normal limits. If total bilirubin is > upper limit of normal (ULN), then subjects are eligible if the direct bilirubin is =2.0 x ULN
- •b. Serum aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 x ULN
- •8. Adequate renal function within 28 days prior to first dose of study treatment defined as an estimated creatinine clearance =30 mL/min by Cockcroft Gault
- •9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •10. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential must both use a highly effective contraception method during the study (Appendix 2). In addition, after the last dose of study drug, female subjects must continue to use a highly effective method of contraception for 1 month and 1 week and male subjects must continue to use a highly effective method of contraception for 3 months and 1 week. A woman is considered of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal) unless permanently sterile (Appendix 2).
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Symptomatic or uncontrolled central nervous system (CNS) metastases. Subjects will not be excluded if they have received definitive local treatment and have documentation of stable or improved CNS disease based on brain imaging within 28 days prior to first dose of study drug, with adequately controlled symptoms, off or on a stable dose of corticosteroids (prednisone =10 mg daily or equivalent).
- •2. Prior treatment with MDM2 inhibitors
- •3. Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment
- •4. Active participation in other therapeutic clinical trials, including supportive care trials
- •5. Uncontrolled clinically significant cardiac disease (New York Heart Class III or IV), symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, history of myocardial infarction within 3 months
- •6. Grade 2 or higher QTc prolongation >480 msec per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
- •7. History of bleeding diathesis; major hemorrhage or intracranial hemorrhage within 24 weeks prior to the first dose of study treatment
- •8. History of another malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with normal prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma
- •9. History of major organ transplant
- •10. Known active hepatitis B or C infection
- •11. Known infection with human immunodeficiency virus
- •12. Clinically significant bacterial, mycobacterial, fungal, parasitic, or viral infection. IV antibiotics within 2 weeks prior to first dose of study treatment
- •13. Known hypersensitivity to or contraindications to the study drug or any of its excipients, or to required prophylaxes
- •14. Major surgery or planned major surgery within 21 days prior to first dose of study treatment
- •15. History of difficult swallowing, gastric or small bowel surgery with history of malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study treatment
- •16. Women who are pregnant or breastfeeding
- •17. Medical condition, serious intercurrent illness, psychiatric condition, or other circumstance (ie, committed to an institution by judicial or administrative authority) that, in the Investigator's judgment, could jeopardize the subject's safety, or that could interfere with study objectives
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