A Phase I, Open Label Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions
研究概览
简要总结
The purpose of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics (PK) of [68Ga]Ga-DWJ155, also known as FKL480, in patients ≥ 18 years of age with advanced gastroesophageal adenocarcinoma (aGEA, where GEA is defined as adenocarcinomas of the distal esophagus, the gastroesophageal junction, and the stomach), hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) advanced breast cancer (aBC), HER2 positive (HER2+) aBC, triple-negative breast cancer (TNBC) and advanced non-small cell lung cancer (aNSCLC) adenocarcinoma.
详细描述
This is an open-label, Phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of [68Ga]Ga-DWJ155.
HER2 status for enrollment will be determined based on the most recent, locally available tumor tissue sample and corresponding HER2 results, in accordance with the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines, as applicable.
This study comprises an imaging characterization part and an expansion part. During the imaging characterization part, the imaging characteristics of [68Ga]Ga-DWJ155 (e.g., biodistribution, tumor uptake, and radiation dosimetry) will be assessed, as well as the optimal imaging time point for tumor visualization. The expansion part may be initiated if positive tumor uptake is observed in patients during the imaging characterization part.
The estimated study duration for each individual patient is up to approximately 32 days, including a screening period of up to 28 days, a single-day imaging period (including [68Ga]Ga-DWJ155 administration and assessments), and a 3-day safety follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patients with one of the following indications:
- •HR+/HER2- aBC and TNBC: untreated or currently receiving or having completed first line of systemic therapy (preferred); HER2+ aBC: regardless of any prior systemic therapy
- •aNSCLC adenocarcinoma: Prior to, during or having completed their first line of systemic therapy. If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+
- •aGEA: regardless of any prior systemic line of therapy
排除标准
- •Out-of-range laboratory values defined as:
- •Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) < 40 mL/min/1.73m2
- •Platelet count < 75 x 10^9/L
- •Hemoglobin < 9 g/dL
- •Absolute neutrophil count (ANC) < 1.0 x 10^9/L
- •Patients with inadequate hepatic function
- •Urinary tract obstruction or urinary incontinence
- •Pregnant or breastfeeding women
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
[68Ga]Ga-DWJ155
Single administration of [68Ga]Ga-DWJ155
干预措施: [68Ga]Ga-DWJ155 (Diagnostic Test)
结局指标
主要结局
Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions
时间窗: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.
Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs
时间窗: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.
次要结局
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 3 days after the administration of [68Ga]Ga-DWJ155)
- Area under the concentration-time curve (AUC) of blood radioactivity (Imaging characterization part only)(From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155)
- Maximum observed concentration (Cmax) of blood radioactivity (Imaging characterization part only)(From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155)
- Absorbed radiation dose in selected organs and total body (Imaging characterization part only)(Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155)
- Effective radiation dose (Imaging characterization part only)(Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155)