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

Phase 1

Recruiting

• Conditions: B7H3; CD276 Affibody; PET/CT Imaing

• Registration Number: NCT06454955
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age range 18-75 years, open to both male and female participants;<br><br> 2. Participants must meet the following hematologic and hepatic/renal function<br> criteria: Hematology: WBC = 4.0 × 10^9/L or neutrophils = 1.5 × 10^9/L, platelets =<br> 100 × 10^9/L, hemoglobin = 90 g/L; Prothrombin time (PT) or Activated partial<br> thromboplastin time (APTT) = 1.5 times the upper limit of normal (ULN); Hepatic and<br> renal functions: Total bilirubin (T-Bil) = 1.5 times the upper threshold limit<br> (ULT), ALT/AST = 2.5 ULN or = 5 ULT for subjects with liver metastasis, Alkaline<br> phosphatase (ALP) = 2.5 ULN (or = 4.5 ULN in cases of bone or liver metastasis);<br> Blood urea nitrogen (BUN) = 1.5 × ULT, serum creatinine (SCr) = 1.5 × ULT;<br><br> 3. Normal cardiac function;<br><br> 4. Expected survival of at least 12 weeks;<br><br> 5. Good adherence to follow-up;<br><br> 6. Presence of at least one measurable target lesion according to RECIST 1.1 criteria;<br><br> 7. Women of childbearing age (15-49 years) must undergo a pregnancy test within seven<br> days prior to the commencement of the study and test negative; sexually active male<br> and female participants must agree to utilize effective contraception to prevent<br> pregnancy during the study and for three months following the final examination;<br><br> 8. Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and<br> staging of tumors;<br><br> 9. Participants must fully understand and voluntarily agree to participate in the<br> study, and must sign an informed consent form.<br><br>Exclusion Criteria:<br><br> 1. Severe abnormalities in liver and renal function and blood counts;<br><br> 2. Patients planning to conceive;<br><br> 3. Pregnant or lactating women;<br><br> 4. Individuals unable to lie flat for thirty minutes;<br><br> 5. Individuals who refuse to participate in this clinical study;<br><br> 6. Individuals suffering from claustrophobia or other psychiatric disorders;<br><br> 7. Other situations deemed unsuitable for trial participation by the researchers.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SUV