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

Early Phase 1

Recruiting

• Conditions: B7H3; PET/CT Imaing; CD276 Affibody
• Interventions: Drug: [68Ga] B7H3 Affibody-BCH

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

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-12
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Each patient must undergo dynamic PET/CT imaging with [68Ga]B7H3 Affibody-BCH.	[68Ga] B7H3 Affibody-BCH	-

Primary Outcome Measures

Name	Time	Method
SUV	1 hour and 2 hour after injection	Standardized Uptake Values (SUV) of \[68Ga\] B7H3 Affibody-BCH at various time points within the imaging window for target lesions or suspected tumor lesions in subjects with malignant tumors.

Trial Locations

Locations (1)

Xiangxi Meng; 🇨🇳 Beijing, Beijing, China