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

Official title

Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET

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.

Interventions

• Drug [68Ga] B7H3 Affibody-BCH
  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.

Primary outcome measures

• SUV [Time frame: 1 hour and 2 hour after injection]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 1 center

• Xiangxi Meng — Beijing

Publications

• Xia L, Wu Y, Ren Y, Wang Z, Zhou N, Zhou W, Zhou L, Jia L, He C, Meng X, Zhu H, Yang Z. A whole-body imaging technique for tumor-specific diagnostics and screening of B7H3-targeted therapies. J Clin Invest. 2025 Jan 23;135(6):e186388. doi: 10.1172/JCI186388. PMID 39847434

Identifiers

NCT: NCT06454955 · 2023KT131

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗