Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute
About this trial
Based on \[68Ga\]B7H3 Affibody-BCH, this study investigates its radioactive uptake and imaging capabilities in tumor patients, with the aim of establishing a correlation between radioactive uptake and B7-H3 receptor expression. Utilizing whole-body PET technology, the pharmacokinetic dynamics of \[68Ga\]B7H3 Affibody-BCH are examined to ascertain its pharmacological characteristics. Ultimately, this research establishes a framework for pharmacokinetic analysis using whole-body PET.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age range 18-75 years, open to both male and female participants;
Participants must meet the following hematologic and hepatic/renal function criteria: Hematology: 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); Hepatic and renal functions: Total bilirubin (T-Bil) ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for subjects with liver metastasis, Alkaline phosphatase (ALP) ≤ 2.5 ULN (or ≤ 4.5 ULN in cases of bone or liver metastasis); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;
Normal cardiac function;
Expected survival of at least 12 weeks;
Disqualifiers
Severe abnormalities in liver and renal function and blood counts;
Patients planning to conceive;
Pregnant or lactating women;
Individuals unable to lie flat for thirty minutes;
Trial design
Design model
Single group
Treatments tested in this trial
[68Ga] B7H3 Affibody-BCH
DrugAn affibody structure specifically targeting B7H3 was developed based on the B7H3 binding domain, and it was structurally optimized to yield a small molecular agent, B7H3 Affibody-BCH, suitable for nuclear medical diagnostic and therapeutic uses targeting B7H3. By labeling with the radioactive isotope \^68Ga, this agent can be used for PET/CT diagnosis of solid tumors.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Each patient must undergo dynamic PET/CT imaging with [68Ga]B7H3 Affibody-BCH.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SUV
Standardized Uptake Values (SUV) of \[68Ga\] B7H3 Affibody-BCH at various time points within the imaging window for target lesions or suspected tumor lesions in subjects with malignant tumors.
Time frame
1 hour and 2 hour after injectionSponsors and contacts
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Source ClinicalTrials.gov