NCT07157033招募中1 期
A Phase 1/2a, Open Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of XER-001 (Amifostibe for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment of Locally-Advanced Pancreatic Adenocarcinoma
Xerient Pharma5 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年1月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Safety Assessments [Dose Escalation and Dose Expansion]
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.
详细描述
The primary objective of the phase 1 component of the study is to evaluate the safety, tolerability, and PK of nasoduodenal administration of XER-001 in conjunction with stereotactic body radiotherapy (SBRT) in patients with LAPC. The primary objective of the phase 2a component of the study is to evaluate safety and efficacy of combination SBRT and XER-001 with increasingly-liberalized duodenal radiation dose constraints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •1. Cytologic or biopsy confirmed adenocarcinoma of the pancreas
- •2. Disease deemed amenable to definitive treatment with SBRT by being:
- •1. Locally-advanced and/or technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team review including of multiphase cross-sectional imaging, demonstrating: i. Greater than 180-degree tumor involvement of the superior mesenteric artery (SMA) ii. Greater than 180-degree tumor involvement of the celiac axis including major branches of the celiac axis that would render the tumor unresectable (e.g. common hepatic artery) iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein/hepatic artery that is not amenable to surgical reconstructible.
- •2. Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid conditions that render.
- •the risks of surgery prohibitive)
- •3. Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT
- •3. Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced imaging) is not allowed.
- •4. No distant metastatic disease either prior to or following induction systemic therapy
- •5. Completion of medically indicated first line systemic therapy, which may include but is not limited to regimens such as FOLFIRNOX, gemcitabine/abraxane, and similar regimens
- •6. Patients must be able to understand and comply with any treatment related procedures for SBRT. including breath-hold techniques or tolerance of compression belt, or other motion management strategies for SBRT delivery.
- •7. Age 18 years or older
- •8. Eastern Cooperative Group (ECOG) performance status 0, 1, or 2
- •9. Adequate hematologic function as indicated by:
- •1. Absolute neutrophil counts \>/= 1500/mm3
- •2. Hemaglobin \>/= 8.0 g/dL
- •3. Plor current use of hepato atelet count \>/= 75,000/mm3
- •10. No known liver disease or hepatic impairment, as well as no recent or current use of hepatotoxic drugs or substances that could compromise liver function unless a washout period has been completed. Adequate liver function as indicated by:
- •1. Total bilirubin \/= 8.4 mg/dL
- •12. No clinically significant history or presence of safety 12-lead ECG findings as judged by the investigator at screening and check-in(s), including each criterion as listed below:
- •1. Normal sinus rhythm (heart rate between 40 and 100 bpm)
- •2. QTcF interval \
排除标准
- •Prior radiotherapy to the upper abdomen with overlap of. the anticipated SBRT field
- •Prior radiopharmaceutical therapy
- •Prior surgical resection of the pancreatic tumor
- •Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
- •Visable invasion of tumor into the bowel/stomach.duodenal lumen on endoscopic evaluation
- •Residual or ongoing grade 3+ non-hemotological toxicity from chemotherapy other than alopecia
- •Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study consent. Note that participation in non-interventional clinical trials (e.g. quality of life [QOL], imaging, etc) is not exclusionary
- •Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia
- •Patients with history of myocardial infarction or unstable angina within 6 months prior to study enrollment
- •Patients with history of symptomatic or (CTCAE-defined) grade 3+ hypocalcemia
- •Patients with history of hypoparathyroidism
- •Patients with history of hypertension where medical providers deem that interruption of antihypertensive regimen for one week is deemed unsafe.
- •Patients with systolic blood pressure (BP) < 100 or diastolic BP < 65 at screening or baseline
- •History or presence of a disease, such as hepatic impairment or renal insufficiency, that could affect the absorption, distribution, metabolism, or elimination of the investigational product, tolerance to radiotherapy, or could affect clinical or laboratory assessments.
- •Patients with an estimated glomerular filtration rate of less than 30 mL per minute are excluded from the trial. Patients with total bilirubin greater than 2.5 mg/dL are excluded from the trial unless patient has history of Gilbert's syndrome. In case of suspected or confirmed Gilbert's syndrome, bilirubin will be fractionated, and patients with direct bilirubin greater than 1.5 mg/dL will be excluded from the trial.
- •History of cardiac-related condition, which may include, but is not limited to, torsades de pointes, ventricular fibrillation, or ventricular tachycardia
- •Presence or family history (parents and siblings) of congenital lqt syndrome or any premature history of myocardial infarction considered clinically significant by the investigator or designee
- •History or presence of palpitations, unexplained syncope, shortness of breath or any other symptoms that may relate to cardiac arrhythmias
- •Any ECG evidence of physiological variants predisposing to electrical instability (eg. frequent pre-ventricular systolic beats)
- •Medical disorder that may require treatment during the study or make the subject unlikely to complete the study.
- •Inability to fast for 3 hours prior to study drug administration
- •Known history of active hepatitis B/C or active human immunodeficiency virus (HIV) not on highly-active anti-retroviral therapy for a minimum of 30 days
- •Donation or loss of more than 500 ml of whole blood within 30 days prior to screening
- •Difficulty with venous access or unstable or unwilling to undergo catheter insertion
- •Female subjects who are currently pregnant (have a positive pregnancy test), are lactating, or planning to breastfeed. Pregnant or breastfeeding women are excluded from this study because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with amifostine, breastfeeding should be discontinued if the mother is treated with amifostine
- •An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- •A subject who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason
研究组 & 干预措施
XER-001 at increasing dose levels
Experimental
干预措施: XER-001 (Drug)
结局指标
主要结局
Safety Assessments [Dose Escalation and Dose Expansion]
时间窗: 40 Months
Number of participants with Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Safety Assessments [Dose Escalation]
时间窗: 18 Months
Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects
Safety Assessments [Dose escalation and Dose Expansion]
时间窗: 40 months
Number of participants with Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
次要结局
- Antitumor Activity(40 Months)
研究者
研究点 (5)
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