Recruiting NCT07070349
A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-6213.
- Who it may be relevant to
- Registry conditions: Patients With Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
Interventions
- Drug HRS-6213
HRS-6213 IV administered as imaging agent for PET scan.
Primary outcome measures
- 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)]
- Phase 1: Radiation dosimetry [Time frame: 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 [Time frame: rom first dose of study drug to end of treatment (up to approximately 60 days)]
Secondary outcome measures (9)
- Phase 1: Cmax [Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)]
- Phase 1: Biological half-life (t½) [Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)]
- Phase 1: Tmax [Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)]
- Phase 1: urinary cumulative excretion rate [Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)]
- Phase 1: Lesion uptake curve [Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)]
- Phase 1: Image quality score [Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)]
- 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)]
- 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)]
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Tianjin Medical University Cancer Institute and Hospital — Tianjin
Identifiers
NCT: NCT07070349 · HRS-6213-101