Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 75

Imaging solid tumors using a targeted radioactive probe

Official title: Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET

Run by Peking University Cancer Hospital & Institute · NCT06454955 · Data updated 2026-11-12

This study is testing a new radioactive probe to see if it can help improve PET imaging of solid tumors in patients by looking at how well it targets a specific protein found in those tumors.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment50 (estimated)
SponsorPeking University Cancer Hospital & Institute
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedNovember 30, 2024
Study endsNovember 30, 2026
Registry record updatedAugust 23, 2024
Trial IDNCT06454955 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-75 with measurable solid tumors and adequate hematologic and organ function.

Probably not a fit

Patients with severe organ dysfunction or those without measurable tumors may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of a radioactive probe, [68Ga]B7H3 Affibody-BCH, for PET imaging of solid tumors. It aims to evaluate the radioactive uptake of the probe and its correlation with B7-H3 receptor expression in tumor patients. The research utilizes whole-body PET technology to analyze the pharmacokinetic dynamics of the probe, establishing a framework for pharmacokinetic analysis in this context. The findings could enhance the understanding of tumor biology and improve imaging techniques.

Why it matters

Potential benefit: If successful, this study could lead to improved imaging techniques for better diagnosis and treatment planning in cancer patients.

How similar studies have gone: Other studies using targeted imaging probes have shown promise, suggesting potential success for this novel approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Xiangxi Meng
    Beijing, Beijing Municipality, China
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

    This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

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  • AKY-2519 (B7‑H3 targeted radioligand) for metastatic castration‑resistant prostate cancer

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  • PD-L1-targeted PET probe to map PD-L1 in solid tumors

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  • 18F-grazy-02 PET/CT to monitor immune therapy in cancer

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  • Firmonertinib given before surgery for EGFR-mutated NSCLC

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.