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

NCT07070349 | Recruiting Phase 1

• 1 other identifier: HRS-6213-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

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

  To evaluate the safety and tolerability of HRS-6213.

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

• Phase 1: Radiation dosimetry

  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

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

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

  evaluate the diagnostic efficacy indicators of HRS-6213.

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

Secondary Outcomes (9)

• Phase 1: Cmax

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

• Phase 1: Biological half-life (t½)

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

• Phase 1: Tmax

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

• Phase 1: urinary cumulative excretion rate

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

• Phase 1: Lesion uptake curve

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

Study Arms (1)

HRS-6213

EXPERIMENTAL

Drug: HRS-6213

Interventions

HRS-6213 DRUG

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

HRS-6213

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Central Study Contacts

Xiao Chen

CONTACT

0518-82342973; xiao.chen.xc1@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: July 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-07

Locations

CN (1)