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NCT Number: NCT07070349

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

The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Jihui Hao

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • Received the following treatments before administration:
  • Received radionuclide diagnostic or therapeutic drugs before administration, and less than 10 physical half-lives have elapsed since the last administration.
  • 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).
  • Concurrent infectious diseases
  • Severe urinary incontinence, hydronephrosis, severe micturition dysfunction.
  • Concurrent severe active infection requiring intravenous antibiotic treatment within 14 days before administration.
  • Unexplained fever > 38.5℃ lasting for more than 1 hour during screening or before administration.
  • 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.

Treatment and study plan

HRS-6213

Drug

HRS-6213 IV administered as imaging agent for PET scan.

Primary outcomes

  1. Phase 1: Incidence of adverse events (AEs) of HRS-6213

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    To evaluate the safety and tolerability of HRS-6213.

  2. Phase 1: Radiation dosimetry

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    To evaluate the distribution of radioactivity in tissues and organs, and obtain the accumulation in major organs, time-radioactivity curves, internal radiation absorbed doses of the whole body and major organs of HRS-6213

  3. Phase 2: With reference to the Standard of Truth (SOT), evaluate the diagnostic efficacy indicators of HRS-6213 PET at the lesion level

    Time frame: rom first dose of study drug to end of treatment (up to approximately 60 days)

    evaluate the diagnostic efficacy indicators of HRS-6213.

Secondary outcomes

  1. Phase 1: Cmax

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    To evaluate the PK of HRS-6213

  2. Phase 1: Biological half-life (t½)

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    To evaluate the PK of HRS-6213

  3. Phase 1: Tmax

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    To evaluate the PK of HRS-6213

  4. Phase 1: urinary cumulative excretion rate

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    To evaluate the PK of HRS-6213

  5. Phase 1: Lesion uptake curve

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    Lesion uptake curve of lesions detected by PET scans at different time points HRS-6213.

  6. Phase 1: Image quality score

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    Imaging quality scores of HRS-6213 with Likert image quality rating scale and signal-to-noise ratio.

  7. Phase 2: The proportion of subjects with changes in disease staging and treatment decisions before and after HRS-6213 PET imaging.

    Time frame: From first dose of study drug to end of treatment (up to approximately 60 days)

    changes in disease staging and treatment decisions due to diagnostic test.

  8. Phase 2: Intra-observer consistency of the diagnosticians' results

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    consistency of the diagnosticians' results by investigators.

  9. Phase 2:Incidence of adverse events (AEs) of HRS-6213

    Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)

    To evaluate the safety and tolerability of HRS-6213.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Chen

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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