Imaging Study of a CAIX Binder in Metastatic Clear Cell RCC.

June 22, 2026 updated by: RayzeBio, Inc.

A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of a Carbonic Anhydrase IX (CAIX) Binder in Subjects With Metastatic Clear Cell Renal Cell Cancer (RCC).

This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a novel Carbonic Anhydrase IX (CAIX) Binder in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • New Zealand
      • Christchurch, New Zealand
        • Research Facility
        • Contact:
          • Site Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imaging Study of a CAIX Binder in Metastatic Clear Cell RCC.
Diagnostic test: RYZ512
Imaging Agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the tolerability of RYZ512 in 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.
Study duration (6 months)
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.
Study duration (6 months)
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 duration (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RayzeBio, Inc.

Investigators

  • Study Director: Heying Duan, MD, RayzeBio, Inc.
  • Study Director: Freddy Escorcia, MD, PhD, RayzeBio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RYZ512-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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