HRS-6213 imaging in healthy volunteers and people with solid tumors

A Phase I/II Clinical Study to Evaluate the Safety, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Efficacy of HRS-6213 in Healthy Subjects and Patients With Solid Tumors

This study will test HRS-6213, a radioactive imaging agent, in healthy volunteers and people with solid tumors to check safety, radiation dose, how it moves through the body, and whether it shows tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07070349 on ClinicalTrials.gov

What this trial studies

HRS-6213 is being studied in a combined Phase 1/2 interventional protocol that enrolls both healthy volunteers and patients with pathologically confirmed solid tumors. Participants receive HRS-6213 followed by serial imaging scans, blood sampling for pharmacokinetics, and radiation dosimetry measurements. Patient participants are adults with ECOG 0-1 who are planned for surgical resection or exploration and have adequate organ function; healthy volunteers must meet BMI 18–28 kg/m2. The study monitors adverse events and collects preliminary diagnostic efficacy data on tumor visualization.

Who should consider this trial

Good fit: Ideal candidates are adults with pathologically confirmed solid tumors who are ECOG 0-1 and scheduled for surgical resection or exploration, as well as healthy volunteers meeting the BMI 18–28 kg/m2 requirement.

Not a fit: Patients with known hypersensitivity to study components, recent radionuclide or contrast exposure, inadequate organ function, or ECOG performance status >1 are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, HRS-6213 could become a safe tumor-targeted imaging agent that improves tumor detection and helps guide surgical planning.

How similar studies have performed: Other radiolabeled imaging agents have successfully aided tumor detection and surgical planning, but HRS-6213 itself is early-stage and has limited human data.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent form; willing and able to follow the study protocol.
2. For healthy subjects：BMI 18\~28kg/m2
3. For patients：

   * ECOG 0-1
   * Patients with pathologically confirmed tumour
   * proposed surgical resection/exploration (including primary or recurrent metastatic tumour
   * sufficient organs function.

Exclusion Criteria:

1. Known severe allergic reactions, hypersensitivity or contraindications to the test drug or any component of its preparation, such as alcohol allergy or other allergic history that the investigator deems may increase the risk of the trial.
2. Received the following treatments before administration:

   1. Received radionuclide diagnostic or therapeutic drugs before administration, and less than 10 physical half-lives have elapsed since the last administration.
   2. Used any intravenous iodinated contrast agent within 24 hours before administration, or used any high-density oral contrast agent within 5 days before administration (oral water-based contrast agent is acceptable).
3. Concurrent infectious diseases
4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction.
5. Concurrent severe active infection requiring intravenous antibiotic treatment within 14 days before administration.
6. Unexplained fever \> 38.5℃ lasting for more than 1 hour during screening or before administration.
7. Concurrent severe or poorly controlled cardiac diseases or symptoms, including but not limited to: NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 6 months before administration, QTcF \> 450 msec in males or QTcF \> 470 msec in females.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiao Chen

Conditions Patients With Solid Tumors