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NCT Number: NCT07671417

Imaging Study in Metastatic Clear Cell RCC.

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).

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Key information

Conditions

Metastatic Clear Cell Renal Cell Carcinoma Clear-cell metastatic renal cell carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Facility

Christchurch, New Zealand

Location contact

Site Contact

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old at the time of signing the informed consent form (ICF).
  • Biopsy proven metastatic clear cell renal cell carcinoma (RCC)

Exclusion criteria

  • 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.

Note: Additional criteria may apply and will be assessed by the study site

Treatment and study plan

RYZ512

Diagnostic Test

Imaging Agent

Primary outcomes

  1. To assess the tolerability of the imaging agent subjects with metastatic clear cell RCC.

    Time frame: Study duration (6 months)

    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.

  2. To evaluate the (long) biodistribution of RYZ512 in subjects with metastatic clear cell RCC.

    Time frame: Study duration (6 months)

    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.

  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.

    Time frame: Study duration (6 months)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

RayzeBio Clinical Trials

CONTACT

[email protected]

(619) 657-0057

Sponsors and collaborators

Lead sponsor

RayzeBio, Inc.

Industry

Registry information

Official study title

A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of the Imaging Agent in Subjects With Metastatic Clear Cell Renal Cell Cancer (RCC).

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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