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

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Xiao Chen
• Email: xiao.chen.xc1@hengrui.com
• Phone: 0518-82342973

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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.