Imaging Study in Metastatic Clear Cell RCC.
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRayzeBio, Inc.
About this trial
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old at the time of signing the informed consent form (ICF).
Biopsy proven metastatic clear cell renal cell carcinoma (RCC)
Disqualifiers
Subjects taking below mentioned medications that cannot be stopped 5 half-lives prior to RYZ512 administration and cannot be restarted until all study-related imaging is completed: Anticonvulsants, Antipsychotics, Carbonic Anhydrase inhibitors, COX-2 Inhibitors, Sulfatase Inhibitors, Sulfonamides
Women of Childbearing Potential that are pregnant or breastfeeding.
Trial design
Design model
Single group
Treatments tested in this trial
RYZ512
Diagnostic testImaging Agent
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Imaging Study in Metastatic Clear Cell RCC.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the tolerability of the imaging agent subjects with metastatic clear cell RCC.
To assess the tolerability of RYZ512 by monitoring incidence and severity of AEs by NCI CTCAE v5, including SAEs, and other safety findings in subjects with metastatic clear cell RCC.
Time frame
Study duration (6 months)2
To evaluate the (long) biodistribution of RYZ512 in subjects with metastatic clear cell RCC.
To evaluate the (long) biodistribution of RYZ512 by using visual assessment of location, extent, and intensity of RYZ512 uptake in critical organs and tumors in subjects with metastatic clear cell RCC.
Time frame
Study duration (6 months)3
To evaluate the radiation absorbed doses of RYZ512 in critical organs and tumors as well as the effective dose in subjects with metastatic clear cell RCC.
To evaluate the radiation absorbed doses of RYZ512 using calculated mean TIAC (MBq·hr/MBq), radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to critical organs (e.g., stomach, liver, kidneys, bone marrow), calculated mean TIAC (MBq·hr/MBq) and radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to tumors, calculated whole-body effective dose (mSv/MBq) in critical organs and tumors as well as the effective dose in subjects with metastatic clear cell RCC.
Time frame
Study duration (6 months)Sponsors and contacts
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Source ClinicalTrials.gov