NCT05475210招募中1 期
Phase I, Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events.
研究概览
简要总结
This is a Phase I clinical trial to assess the safety and dosimetry profiles of 177Lu-DOTA-EB-TATE in patients with advanced, metastatic or inoperable, somatostatin receptor-positive, well-differentiated GEP-NETs.
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
- •Ability to understand and willing to sign a written informed consent document
- •Aged 18 years or older
- •Histologically proven or cytologically confirmed, inoperable, GEP-NETs
- •Neuroendocrine tumors (NETs) of grade 1, 2 and 3 according to World Health Organization (WHO) 2017 classification
- •Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1
- •Overexpression of somatostatin receptors of the target lesions in 68Ga-DOTA-TATE positron emission tomography (PET)/computed tomography (CT) with SUV of lesions greater than normal liver in at least 1 lesion
- •A Cockcroft Gault calculated creatinine clearance > 60 mL/min
- •Karnofsky performance status scale ≥ 70%
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including follow-up (7 months after the last dose of study drug for women and 4 months for men).
- •Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed >4 weeks prior to study entry.
- •Previous surgery no less than 6 weeks prior to study entry.
- •Either no prior treatment with 177Lu-DOTA-TATE or at least 12 months progression-free survival (PFS) after prior treatment with 177Lu-DOTA-TATE
排除标准
- •Women who are pregnant or breastfeeding
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-EB-TATE as assessed from medical records
- •Previous treatment with more than 4 cycles of 177Lu-DOTA-TATE
- •Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives whichever is longer, before the first administration of study drug.
- •Participant has not fully recovered from major surgery or significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug.
- •Life expectancy < 6 months as assessed by the treating physician
- •> 80% liver involvement by tumor
- •> 25% bone marrow involvement by tumor
- •Poorly differentiated neuroendocrine neoplasms, such as poorly differentiated neuroendocrine carcinoma, small- and large-cell neuroendocrine carcinoma; mixed neuroendocrine-non-neuroendocrine neoplasm (MiNEN); Grade 3 neuroendocrine carcinomas (NEC)
- •Presence of somatostatin receptor negative lesions if they cannot be addressed with loco-regional therapies prior to the treatment start
- •Deteriorated renal function, as indicated by a serum creatinine clearance > 1.7 mg/dL
- •Deteriorated bone marrow function
- •Deteriorated liver function
- •Toxicities from prior therapies that have not resolved to grade 1 or grade 0
- •Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B (HBV), hepatitis C (HBC), know human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
- •Known brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized
- •Uncontrolled diabetes mellitus as defined by a HbA1c >9%
- •Impossibility to interrupt short-acting octreotide for 24 h before and 24 h after the administration of 177Lu-DOTA-EB-TATE; impossibility to have an interval of ≥4 weeks between octreotide and 177Lu-DOTA-EB-TATE
- •The use of somatostatin and its analogues within 4 months of a planned 177Lu-DOTA-EB-TATE treatment
- •Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Prior external beam radiation therapy involving >25% of the bone marrow
- •Unmanageable urinary incontinence rendering the administration of 177Lu-DOTA-EB-TATE unsafe
- •Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence
研究组 & 干预措施
Peptide Receptor Radionucleotide Therapy (PRRT)
Experimental
The treatment regimen will consist of a single-dose intravenous administration of 177Lu-DOTA-EB-TATE per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels, from 50 mCi to 150 mCi (1.85 -5.55 GBq). Each dose of 177Lu-DOTA-EB-TATE will be administered in association with intravenous renal protective amino acid solutions.
干预措施: 177Lu-DOTA-EB-TATE (Drug)
Peptide Receptor Radionucleotide Therapy (PRRT)
Experimental
The treatment regimen will consist of a single-dose intravenous administration of 177Lu-DOTA-EB-TATE per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels, from 50 mCi to 150 mCi (1.85 -5.55 GBq). Each dose of 177Lu-DOTA-EB-TATE will be administered in association with intravenous renal protective amino acid solutions.
干预措施: Amino Acid Solution (Other)
结局指标
主要结局
To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events.
时间窗: 16-17 months
To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu-DOTA-EB-TATE up to 150 mCi.
时间窗: 16-17 months
To determine if the maximum tolerated dose is among the explored doses of 50, 100 and 150 mCi.
时间窗: 16-17 months
次要结局
- To evaluate the differential safety of 177Lu-DOTA-EB-TATE, expressed as the number of patients with treatment-related adverse events following 177Lu-DOTA-EB-TATE.(16-17 months)
- To evaluate dosimetry levels in patients following 2 cycles of 177Lu-DOTA-EB-TATE.(16-17 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and AtezolizumabExtensive Stage Small Cell Lung CancerNCT05142696Novartis Pharmaceuticals55
已完成
1 期
Study of TAK-901 in Adults With Advanced Solid Tumors or LymphomaAdvanced Solid TumorsLymphomaNCT00935844Millennium Pharmaceuticals, Inc.20
已完成
1 期
Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple MyelomaRelapsed and Refractory Multiple MyelomaNCT00932698Millennium Pharmaceuticals, Inc.60
招募中
1 期
A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed/Refractory LymphomaAdvanced Solid TumorLymphomaHCCNSCLCNCT05341557Betta Pharmaceuticals Co., Ltd.110
已完成
1 期
Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or MetastaticTumorsNCT00127829AstraZeneca66