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RecruitingNCT07671417Updated Sep 29, 2026

Imaging Study in Metastatic Clear Cell RCC.

An Early Phase 1 interventional study of RYZ512 in Metastatic Clear Cell Renal Cell Carcinoma, sponsored by RayzeBio, Inc.. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by RayzeBio, Inc. · Early Phase 1, Interventional, and Diagnostic

Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Metastatic Clear Cell Renal Cell Carcinoma

Keywords

  • RCC
  • Metastatic RCC
  • Metastatic Clear Cell Renal Cancer
  • RayzeBio
  • Rayze
  • BMS
  • Bristol Myers Squibb
  • RPT
  • Imaging Agent
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

04

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Imaging Study in Metastatic Clear Cell RCC.

    Diagnostic Test: RYZ512

Interventions

  • Diagnostic testRYZ512

    Imaging Agent

05

What researchers measure

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)

06

Study locations

4 of 4 sites recruiting
  • Research Facility
    Saint Leonards, New South Wales, Australia
    Recruiting
  • Research Facility
    Nedlands, Australia
    Recruiting
  • Research Facility
    Perth, Australia
    Recruiting
  • Research Facility
    Christchurch, New Zealand
    Recruiting
07

Registry details

Key details

Study ID
NCT07671417
Lead sponsor
RayzeBio, Inc.
Responsible party
Sponsor
First posted
Jun 26, 2026
Start date
Jun 15, 2026
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

RayzeBio Clinical Trials
Contact
clinicaltrials@rayzebio.com
(619) 657-0057
Freddy Escorcia, MD, PhD
study director · RayzeBio, Inc.
Heying Duan, MD
study director · RayzeBio, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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