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First Human Trial of Targeting MDM2/MDMX PET Imaging | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

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

NCT06443762•Peking University Cancer Hospital & Institute

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Ages 18 to 75 years, both males and females are eligible;
•2. Participants must meet the following criteria for blood routine and liver/kidney function tests: Complete blood count: WBC ≥ 4.0 × 10\^9/L or neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); liver and kidney function: Total bilirubin ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for participants with liver metastasis, alkaline phosphatase (ALP) ≤ 2.5 ULN (if bone or liver metastases are present, ALP ≤ 4.5 ULN); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;
•3. Normal cardiac function;
•4. An expected survival of ≥ 12 weeks;
•5. Good follow-up compliance;
•6. According to RECIST 1.1 criteria, there must be at least one measurable target lesion;
•7. Women of childbearing age (15-49 years) must have a negative pregnancy test conducted within 7 days prior to enrollment; patients of childbearing potential must agree to use effective contraceptive methods to ensure they do not conceive during the study and for three months after examinations;
•8. Patients recommended for PET/CT evaluation for tumor diagnosis and staging by a clinician;
•9. Participants must fully understand the study and voluntarily participate, and must sign an informed consent form.

Exclusion Criteria

•1. Severe abnormalities in liver and kidney function as well as hematological parameters;
•2. Patients who are planning a pregnancy;
•3. Pregnant or lactating women;
•4. Individuals unable to lie flat for thirty minutes;
•5. Individuals who refuse to participate in this clinical study;
•6. Individuals suffering from claustrophobia or other psychiatric disorders;
•7. Other conditions deemed by the researchers as unsuitable for participation in the trial.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

January 3, 2025

Primary Completion Date

May 1, 2025

Completion Date

May 23, 2025

Last Updated

May 31, 2025

Enrollment

ACTUAL participants

Conditions

MDM2/MDMX Gene MutationNuclear MedicinePositron Emission Tomography Imaing

Interventions

[68Ga] MDM2/MDMX Peptide

DRUG

Pilot Evaluation of the StarGuide Next Generation SPECT/CT System

NCT07272161

Nuclear Medicine

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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