Clinical trial · Observational
First-in-Human Study of the Radioligand 68Ga- DOTA-EphA2
Development and Evaluation of 68Ga-DOTA-EphA2: A Novel Imaging Agent Targeting EphA2 for Malignant Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose Ephrin type-A receptor 2 (EphA2) is a receptor tyrosine kinase overexpressed in various solid tumors and associated with tumor progression, metastasis, and poor prognosis. However, noninvasive imaging tools for assessing EphA2 expression in vivo remain limited. This study aims to develop a novel 68Ga-labeled EphA2-targeting positron emission tomography (PET) tracer for specific imaging of EphA2-positive malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Enrolled patients
- description
- Patients with Malignant Tumor
- interventionNames
- Device: 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor
Primary outcomes (3)
- measure
- Number of Participants With Treatment-Emergent Adverse Events Following ⁶⁸Ga-NOTA-EphA2
- timeFrame
- From tracer administration to 24 hours after tracer injection.
- description
- Number of participants experiencing treatment-emergent adverse events (TEAEs) after administration of ⁶⁸Ga-NOTA-EphA2, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- measure
- Biodistribution of ⁶⁸Ga-NOTA-EphA2 Measured by Standardized Uptake Value (SUV)
- timeFrame
- From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 18-80 years * Patients with suspected or histologically confirmed malignant tumors At least one measurable lesion identified by conventional imaging (CT, MRI, or ultrasound) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Ability to understand the study procedures and provide written informed consent * Adequate organ function allowing PET/CT examination Exclusion Criteria: * Pregnant or breastfeeding women * Severe hepatic, renal, cardiovascular, or pulmonary dysfunction considered --unsuitable for PET/CT imaging * Known allergy or hypersensitivity to study-related compounds * Patients unable to tolerate PET/CT examination or remain still during image acquisition * Participation in other investigational drug or radionuclide studies within 4 weeks prior to enrollment * Any medical or psychiatric condition judged by the investigators to interfere with study participation or interpretation of imaging results
References
Publications (1)
- BACKGROUNDZhang MJ, Chen Y, Zhang C, Bian X, Zhang X, Huang S, Yang B, Lu S, Fu X, Zhao W, Kong XD, Zhao S. Development of a 177Lu-labeled EphA2-targeting cyclic peptide combined with an HPK1 inhibitor for synergistic anti-tumor effects. Cell Oncol (Dordr). 2025 Dec;48(6):1757-1774. doi: 10.1007/s13402-025-01105-1. Epub 2025 Oct 2. PMID 41037223