NCT06443762

First Human Trial of Targeting MDM2/MDMX PET Imaging

First in Human Study on PET Imaging of Solid Tumors Using an MDM2/MDMX-Specific Probe

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Investigation of the Radiotracer Uptake of \[68Ga\] MDM2/MDMX Peptide at Lesion Sites in Patients with Malignant Tumors, and Evaluation of the Capability of \[68Ga\] MDM2/MDMX Peptide to Detect Overexpression of MDM2/MDMX in Tumor Patients, Particularly Those with Recurrent or Advanced Disease.

Conditions

• MDM2/MDMX Gene Mutation
• Nuclear Medicine
• Positron Emission Tomography Imaing

Interventions

Type	Name	Description
DRUG	[68Ga] MDM2/MDMX Peptide	Utilizing a peptide with high affinity to MDM2/MDMX as the targeting moiety for radiopharmaceuticals, this study explores the diagnostic efficacy of \[68Ga\] MDM2/MDMX Peptide in patients with malignant tumors exhibiting high MDM2/MDMX expression. This approach not only provides a basis for the early diagnosis of malignant tumors but also facilitates the formulation of effective precision therapy strategies tailored to the tumor's MDM2/MDMX expression profile, particularly for patients with recurrent and metastatic disease. \[68Ga\] MDM2/MDMX Peptide, a novel MDM2/MDMX-targeted molecular probe labeled with 68Ga, utilizes DOTA as a bifunctional chelator for complexing with 68Ga3+. The labeling process is straightforward, allowing for direct use without purification, and demonstrates high in vivo stability.

Timeline

• Start date: 2025-01-03
• Primary completion: 2025-05-01
• Completion: 2025-05-23
• First posted: 2024-06-05
• Last updated: 2025-05-31

Locations

1 site across 1 country: China