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Clinical Trials in China / NCT06454955
Recruiting Phase EARLY_PHASE1

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

NCT06454955 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Cancer Hospital & Institute
Phase
Phase EARLY_PHASE1
Started
2024-01-01
Last updated
2024-08-23

Condition(s) studied

B7H3CD276 AffibodyPET/CT Imaing

Investigational drug(s) / intervention(s)

[68Ga] B7H3 Affibody-BCH

[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.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age range 18-75 years, open to both male and female participants; 2. 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; 3. Normal cardiac function; 4. Expected survival of at least 12 weeks; 5. Good adherence to follow-up; 6. Presence of at least one measurable target lesion according to RECIST 1.1 criteria; 7. 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; 8. Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors; 9. Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form. Exclusion Criteria: 1. Severe abnormalities in liver and renal function and blood counts; 2. Patients planning to conceive; 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 situations deemed unsuitable for trial participation by the researchers.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xiangxi Meng Beijing Beijing Municipality Recruiting

More Peking University Cancer Hospital & Institute trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06454955 on ClinicalTrials.gov ↗ ← All trials in China