TheranosticTrials.org

Clinical Trial · NCT06454955

Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors

Overview

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.

Sponsor

Peking University Cancer Hospital & Institute

Phase

Early Phase 1

ClinicalTrials.gov

NCT06454955

Drug / Compound

B7H3 Affibody-BCH

Isotope(s):
Target(s):
  • B7H3
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DOTA

Eligibility

Inclusion

  • Good adherence to follow-up;
  • Presence of at least one measurable target lesion according to RECIST 1.1 criteria;
  • Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors;
  • Expected survival of at least 12 weeks;
  • Normal cardiac function;
  • 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;

Exclusion

  • Individuals who refuse to participate in this clinical study;
  • Individuals suffering from claustrophobia or other psychiatric disorders;
  • Patients planning to conceive;
  • Severe abnormalities in liver and renal function and blood counts;
  • Individuals unable to lie flat for thirty minutes;
  • Other situations deemed unsuitable for trial participation by the researchers.
  • Pregnant or lactating women;