NCT07639970尚未招募1 期
Evaluation of the Safety, Biodistribution and Human Dosimetry of [68Ga]Ga-HT547 PET/CT and [177Lu]Lu-HT547 SPECT/CT in the Clinical Diagnosis of Solid Tumor Patients
Hua Pang0 个研究点目标入组 20 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
Urokinase plasminogen activator receptor (uPAR), the cell-surface receptor for its ligand uPA, plays a critical role in regulating cell migration and invasion-key drivers of cancer progression. This study aims to evaluate a novel uPAR-targeting radiopharmaceutical pair: the diagnostic agent [⁶⁸Ga]Ga-HT547 and the therapeutic agent [¹⁷⁷Lu]Lu-HT547. In patients with breast cancer, head and neck cancer, pancreatic cancer, or glioma, we will assess the diagnostic performance and biodistribution of these tracers using [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547 SPECT/CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to communicate with the investigator, understand and comply with trial requirements, voluntarily participate in the trial, and provide written informed consent.
- •Aged 18 years or older, regardless of gender.
- •Expected survival of at least 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Patients with solid tumors (breast cancer, head and neck cancer, pancreatic cancer, or brain glioma) confirmed by histology or cytology.
- •Radiographic evidence of disease progression within 12 months prior to screening (according to RECIST 1.1 criteria).
- •At least one measurable target lesion according to RECIST 1.1 criteria.
- •Positive uptake in the target lesion on ⁶⁸Ga-HT547 Positron Emission Tomography (PET) scan, with SUV ≥
- •Recovery from toxicities related to prior therapy to ≤ Grade 1 or baseline (except for alopecia, vitiligo, etc.).
- •For subjects of childbearing potential: Agreement to remain abstinent or use effective contraception (including intrauterine devices, etc.) from signing the ICF until at least 24 weeks after the last dose.
排除标准
- •Pregnant or breastfeeding women, or women with a positive baseline pregnancy test.
- •History of severe allergic reaction to any component of the investigational drug injection.
- •Received blood transfusion within 4 weeks prior to screening to meet the enrollment criteria.
- •Received immunotherapy, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.
- •Received any investigational drug within 28 days prior to the first dose, or concurrent participation in another clinical study (except: participation in an observational, non-interventional study, or being in the follow-up phase of an interventional study).
- •History of other known malignancies within the past 5 years.
- •Presence of symptomatic or unstable third-space effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.
- •Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
- •Inadequate organ function (meeting any of the following):
- •Bone marrow reserve: Neutrophil count < 1.5 x 10⁹/L, or platelet count < 100 x 10⁹/L, or hemoglobin < 90 g/L.
- •Liver function: AST/ALT > 3 x ULN (> 5 x ULN for subjects with liver metastases), or albumin ≤ 2.8 g/dL, or total bilirubin > 1.5 x ULN.
- •Renal function: Serum creatinine > 1.5 x ULN and creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula).
- •Severe cardiovascular clinical diseases or symptoms that may increase subject safety risk, including:
- •Congestive heart failure (New York Heart Association [NYHA] class > II) within the past year.
- •Unstable angina within the past year.
- •Myocardial infarction within the past year.
- •Clinically significant malignant arrhythmia (except for atrial fibrillation, paroxysmal supraventricular tachycardia).
- •Presence of clinically significant QTcF prolongation (QTcF > 470 ms, calculated by Fridericia's formula).
- •Clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 14 days prior to the first dose.
- •Major surgery or significant trauma within 28 days prior to the first dose.
- •Any other condition that, in the investigator's judgment, may increase safety risk or interfere with its interpretation.
- •Inability of the subject to understand and comply with study instructions and requirements.
- •Any other situation deemed inappropriate by the investigator.
研究者
Hua Pang
Chief Physician
First Affiliated Hospital of Chongqing Medical University
相似试验
尚未招募
2 期
Treatment of Haemorrhoid (Bawaseer) with Unani Medicine Habb-e-AnjeerCTRI/2025/08/092362Central Council for Research in Unani Medicine CCRUM New Delhi110
招募中
不适用
Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative ColitisNCT07442045Sixth Affiliated Hospital, Sun Yat-sen University150
招募中
1 期
Clinical Study of UTAA07 Injection in the Treatment of Hematologic and Lymphatic Systemic MalignanciesNCT07338604PersonGen BioTherapeutics (Suzhou) Co., Ltd.15
尚未招募
2 期
Treatment of Khafaqan (Palpitation) with the Unani Medicine Jawarish-e-Tamar Hindi and Jawarish-e-ShahiCTRI/2026/03/105563Central Council for Research in Unani Medicine318
尚未招募
2 期
Treatment of Early Seminal Discharge (Premature Ejaculation) with Unani Medicine Majoon-e-Mughalliz and Majoon-e-Piyaz.CTRI/2025/12/099550Central Council for Research in Unani Medicine210