Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors
Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET
Peking University Cancer Hospital & Institute
50 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria9
- 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;
- Good adherence to follow-up;
- Presence of at least one measurable target lesion according to RECIST 1.1 criteria;
- Women of childbearing age (15-49 years) must undergo a pregnancy test within seven days prior to the commencement of the study and test negative; sexually active male and female participants must agree to utilize effective contraception to prevent pregnancy during the study and for three months following the final examination;
- Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors;
- Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.
Exclusion Criteria7
- 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;
- Individuals who refuse to participate in this clinical study;
- Individuals suffering from claustrophobia or other psychiatric disorders;
- Other situations deemed unsuitable for trial participation by the researchers.
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Interventions
An 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06454955