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Trial Title:
Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors
NCT ID:
NCT06454955
Condition:
B7H3
CD276 Affibody
PET/CT Imaing
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga] B7H3 Affibody-BCH
Description:
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.
Arm group label:
Each patient must undergo dynamic PET/CT imaging with [68Ga]B7H3 Affibody-BCH.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Xiangxi Meng
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangxi Meng, PhD
Phone:
01088197852
Email:
mengxiangxi@pku.edu.cn
Contact backup:
Last name:
Lei Xia, PhD
Phone:
01088197853
Email:
xialei9012288@126.com
Start date:
January 1, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06454955
