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

NCT06454955 | Recruiting Early Phase 1

• 1 other identifier: 2023KT131
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

EXPERIMENTAL

Drug: [68Ga] B7H3 Affibody-BCH

Interventions

[68Ga] B7H3 Affibody-BCH 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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 18-75 years, open to both male and female participants;
• 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;
• Normal cardiac function;
• Expected survival of at least 12 weeks;
• Good adherence to follow-up;
• Presence of at least one measurable target lesion according to RECIST 1.1 criteria;
• 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;
• Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors;
• Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.

You may not qualify if:

• Severe abnormalities in liver and renal function and blood counts;
• Patients planning to conceive;
• Pregnant or lactating women;
• Individuals unable to lie flat for thirty minutes;
• Individuals who refuse to participate in this clinical study;
• Individuals suffering from claustrophobia or other psychiatric disorders;
• Other situations deemed unsuitable for trial participation by the researchers.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Xiangxi Meng

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39847434 DERIVED

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 12, 2024
• Study Start: January 1, 2024
• Primary Completion: November 30, 2024
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-01

Locations

CN (1)