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

NCT ID: NCT06454955

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-11-30

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.

Conditions

B7H3; CD276 Affibody; PET/CT Imaing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

[68Ga] B7H3 Affibody-BCH

Intervention Type: DRUG

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.

Interventions

[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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangxi Meng

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xiangxi Meng, PhD

Role: primary

mengxiangxi@pku.edu.cn

01088197852

Lei Xia, PhD

Role: backup

xialei9012288@126.com

01088197853

References

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.

Reference Type: DERIVED

PMID: 39847434 (View on PubMed)

Other Identifiers

2023KT131

Identifier Type: -

Identifier Source: org_study_id