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

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

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.

Study Overview

• Status: Recruiting
• Conditions: B7H3; CD276 Affibody; PET/CT Imaing
• Intervention / Treatment: Drug: [68Ga] B7H3 Affibody-BCH

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Xiangxi Meng
      • Contact: Xiangxi Meng, PhD; Phone Number: 01088197852; Email: mengxiangxi@pku.edu.cn
      • Contact: Lei Xia, PhD; Phone Number: 01088197853; Email: xialei9012288@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Each patient must undergo dynamic PET/CT imaging with [68Ga]B7H3 Affibody-BCH.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUV	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.	1 hour and 2 hour after injection

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023KT131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No