Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07070349

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

Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-08-12

48

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign the informed consent form and be willing and able to follow the study protocol
  • For healthy subjects: BMI between 18 and 28 kg/m2
  • For patients: ECOG performance status 0-1
  • For patients: Pathologically confirmed tumor
  • For patients: Planned surgical resection or exploration, including primary or recurrent metastatic tumor
  • For patients: Sufficient organ function
Not Eligible

You will not qualify if you...

  • Known severe allergic reactions or hypersensitivity to the test drug or its components, including alcohol allergy
  • Received radionuclide diagnostic or therapeutic drugs less than 10 physical half-lives before administration
  • Used intravenous iodinated contrast agent within 24 hours before administration
  • Used high-density oral contrast agent within 5 days before administration (oral water-based contrast agents are allowed)
  • Presence of concurrent infectious diseases
  • Severe urinary incontinence, hydronephrosis, or severe urination dysfunction
  • Severe active infection requiring intravenous antibiotics within 14 days before administration
  • Unexplained fever above 38.5°C lasting more than 1 hour during screening or before administration
  • Severe or poorly controlled cardiac diseases or symptoms, including NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 6 months, or prolonged QTcF interval (above 450 msec in males or 470 msec in females)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

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Research Team

X

Xiao Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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