NCT05226494进行中（未招募）1 期
A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven intracranial glioblastoma, with first or second recurrence
- •On stable or decreasing dose of steroids, if taken prior to screening
- •Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT
- •Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery/biopsy and radiotherapy
- •Confirmation of true progressive disease for patients previously treated with interstitial brachytherapy or stereotactic radio surgery
- •Life expectancy of more than three months
- •Karnofsky Performance Status of ≥ 70
- •Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication
- •Adequate bone marrow and organ function, confirmed by laboratory testing at screening
- •Patient or caregiver must be able to store drug under refrigerated conditions, prepare and administer daily subcutaneous injections on a set schedule, and record information in a daily treatment diary
- •Women of childbearing potential must agree to ongoing pregnancy testing and to use medically acceptable contraception for the duration of the study and for 2 months after their last dose of study drug
- •Males must agree to use medically acceptable contraception and refrain from donating sperm for the duration of the study and for 2 months after their last dose of study drug
排除标准
- •Significant medical illness that is uncontrolled, may obscure toxicity, may dangerously alter drug metabolism, or may compromise ability for study participation
- •History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug
- •Use of bevacizumab or any other experimental drug or therapy within 28 days of study treatment
- •Prior therapy with fb-PMT or related drugs
- •Currently pregnant or breastfeeding
- •Active infection or serious intercurrent medical illness
- •Surgery of any type within the preceding 28 days that has not fully healed
- •A serious or non-healing wound, ulcer, or bone fracture
- •A known bleeding diathesis or coagulopathy, or a history of bleeding diathesis within 28 days of study treatment
- •A known thrombophilic condition (i.e., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome). Testing is not required in patients without thrombophilic history.
- •Evidence of new central nervous system hemorrhage on baseline MRI obtained within 14 days prior to study enrollment
- •Clinically significant cardiovascular event such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
- •New York Heart Association classification of heart disease greater than Class 2
- •QTc interval > 450 msec in males or > 470 msec in females at screening
- •Use of concomitant medications that prolong the QT/QTc interval or risk inducing Torsades de Pointes
- •Use of any concomitant OATP1B1, OATP1B3, or BSEP inhibitors within 14 days or five half-lives (whichever is longer) before starting study drug treatment
- •Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment
- •A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study enrollment
- •History of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months
- •History of Torsades de Pointes or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
研究组 & 干预措施
Treatment (fb-PMT)
Experimental
Daily subcutaneous injection of fb-PMT in four escalating cohorts to determine maximum tolerated dose, followed by treatment of up to 10 additional patients at maximum tolerated dose.
干预措施: fb-PMT (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 15 months
Determined by the number of Treatment-Emergent Adverse Events, including Dose-Limiting Toxicities per patient.
Incidence of Dose Limiting Toxicities [Safety and Tolerability]
时间窗: 28 Days
Number of participants with a dose-limiting toxicity during the first cycle (28 days) of treatment at their highest dose level administered.
次要结局
- Establishment of Recommended Phase 2 Dose(28 Days)
研究者
研究点 (2)
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