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RecruitingNCT07671092Updated Sep 29, 2026

Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC

An Early Phase 1 interventional study of RYZ211/212 in Metastatic Urothelial Carcinoma, Breast Cancer and TNBC - Triple-Negative Breast Cancer, 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
40
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 UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.

02

Conditions studied

  • Metastatic Urothelial Carcinoma
  • Breast Cancer
  • TNBC - Triple-Negative Breast Cancer
  • Hormone Receptor Positive HER-2 Negative Breast Cancer
  • NSCLC

Keywords

  • HR+
  • HER2-
  • Breast Cancer
  • Non Small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • TNBC
  • 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

  • Are at least 18 years old at the time of signing the informed consent form (ICF)
  • Have biopsy proven metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC

Exclusion criteria

Exclusion Criteria:

  • For Women of Childbearing Potential: 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
40 participants (estimated)

Study arms

  • Experimental
    RYZ211/212

    Diagnostic Test: RYZ211/212

Interventions

  • Diagnostic testRYZ211/212

    Imaging Agent

05

What researchers measure

Primary outcomes

  1. To evaluate the biodistribution of RYZ211 in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC

    To evaluate the biodistribution of RYZ211 using SUV (mean, maximum, and peak) of critical organs (blood pool, salivary glands, thyroid, pancreas, liver, kidney \[cortex\], bone) and tumors; tumor-to-normal organ tracer uptake ratios in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC

    Time frame: Study duration (1 year)

  2. To evaluate the long biodistribution and radiation absorbed doses in critical organs and tumors, and the effective dose of RYZ212 in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC

    To evaluate the long biodistribution and radiation absorbed doses in critical organs and tumors, and the effective dose of RYZ212 by using calculated mean TIAC (MBq · h/MBq), radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to critical organs (salivary glands, thyroid, pancreas, liver, kidneys, bone marrow), calculated mean TIAC (MBq · h/MBq) and radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to tumors, calculated whole-body effective dose (mSv/MBq)

    Time frame: Study duration (1 year)

06

Study locations

4 of 4 sites recruiting
  • Research Facility
    St 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
NCT07671092
Lead sponsor
RayzeBio, Inc.
Responsible party
Sponsor
First posted
Jun 26, 2026
Start date
Jun 15, 2026
Primary completion
Aug 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

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