Clinical trial NCT06454955: Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors
Official title: Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: B7H3
CD276 Affibody
PET/CT Imaing
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: SUV
timeFrame: 1 hour and 2 hour after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiangxi Meng
state: Beijing
Study officials:
References: