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

NCT ID: NCT07070349

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2026-03-31

Brief Summary

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

Conditions

Patients With Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

HRS-6213

Group Type: EXPERIMENTAL

HRS-6213

Intervention Type: DRUG

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

Interventions

HRS-6213

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao Chen

Role: CONTACT

xiao.chen.xc1@hengrui.com

0518-82342973

Other Identifiers

HRS-6213-101

Identifier Type: -

Identifier Source: org_study_id