A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jul 8, 2025

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ClinConnect Summary

This clinical trial is studying a new drug called HRS-6213 to see if it is safe and how it works in the body, especially for people with solid tumors (a type of cancer that forms lumps in organs or tissues). The study will also look at how well the drug helps doctors see tumors during imaging tests. Right now, the trial is not yet recruiting participants.

People who may join the study include healthy adults with a certain body weight range and patients who have been diagnosed with solid tumors and are planning to have surgery. To be eligible, patients need to be in good overall health, able to follow the study rules, and have normal organ function. The study will not accept people who have serious allergies, recent treatments that might interfere with the drug, ongoing infections, certain urinary or heart problems, or recent fevers. If you join, you can expect to have the drug given and then have tests to monitor its safety and how it behaves in your body. This early-phase trial helps researchers understand if HRS-6213 could be useful for diagnosing tumors in the future.

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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.