The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
48
HRS-6213 IV administered as imaging agent for PET scan.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGPhase 1: Incidence of adverse events (AEs) of HRS-6213
To evaluate the safety and tolerability of HRS-6213.
Time frame: 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
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
evaluate the diagnostic efficacy indicators of HRS-6213.
Time frame: rom first dose of study drug to end of treatment (up to approximately 60 days)
Phase 1: Cmax
To evaluate the PK of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Biological half-life (t½)
To evaluate the PK of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Tmax
To evaluate the PK of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: urinary cumulative excretion rate
To evaluate the PK of HRS-6213
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Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Lesion uptake curve
Lesion uptake curve of lesions detected by PET scans at different time points HRS-6213.
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Image quality score
Imaging quality scores of HRS-6213 with Likert image quality rating scale and signal-to-noise ratio.
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.
changes in disease staging and treatment decisions due to diagnostic test.
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
consistency of the diagnosticians' results by investigators.
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
To evaluate the safety and tolerability of HRS-6213.
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)