NCT06454955 Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors
| NCT ID | NCT06454955 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Peking University Cancer Hospital & Institute |
| Condition | B7H3 |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2024-01-01 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Frequently Asked Questions
Who can join the NCT06454955 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying B7H3. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06454955 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06454955 currently recruiting?
Yes, NCT06454955 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peking University Cancer Hospital & Institute to inquire about joining.
Where is the NCT06454955 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06454955 clinical trial?
NCT06454955 is sponsored by Peking University Cancer Hospital & Institute. The trial plans to enroll 50 participants.