ClinicalTrials.gg
RecruitingNCT07671092Updated Oct 13, 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 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by RayzeBio, Inc. (part of Bristol-Myers Squibb) · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Oct 13, 2026Now RecruitingFirst sites in Australia and South Africa+4 moreGo to Updates ↓

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Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 12 studies in Carcinoma, Transitional Cell by Bristol-Myers Squibb — 2 open to participants now, 2 under way, none of them phase 3. Carcinoma, Transitional Cell · Bristol-Myers Squibb.

Planned enrollment
7th of 11
40 · median 67
Started
2026
the only one that year
Phase 1
4 of 12
1 open now
Registered
12th of 12
by date

Among the 12 studies in Carcinoma, Transitional Cell by Bristol-Myers Squibb, this one is the 7th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 4 in phase 1, and was the 12th registered.

Carcinoma, Transitional Cell

633 studies on the registry are indexed under Carcinoma, Transitional Cell; 180 are open to participants now.

Browse Carcinoma, Transitional Cell studies →

Open to participants now

2 of the 12 studies in Carcinoma, Transitional Cell by Bristol-Myers Squibb are open now, in 10 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 147 Carcinoma, Transitional Cell studies recruiting now, 121 (82%) set no upper age limit and 11 (7%) stop at 75 or younger; 4 take children under 18; 8 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Carcinoma, Transitional Cell by Bristol-Myers Squibb, or all of them as a file.
02

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.

03

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
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • For Women of : Are pregnant or breastfeeding

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

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

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

06

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)

07

Study locations

4 of 6 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
  • Research Facility
    Johannesburg, South Africa
    Active, not recruiting

    Not enrolling at this site.

  • Research Facility
    Pretoria, South Africa
    Active, not recruiting

    Not enrolling at this site.

08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Aug 2027, 14 months after the start.

Of 62 industry-sponsored phase 1 interventional studies under Carcinoma, Transitional Cell, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 57. This study's planned 14 months is below that.

Counting every sponsor, half of 99 studies reached it within 44 months; a quarter within 31 and three quarters within 63.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Jul 2027 → Aug 2027 and completion Oct 2027 → Nov 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2026
First posted
Jun 26, 2026
StartActual
Jun 15, 2026
Primary completionEst.
Aug 2027was Jul 2027
CompletionEst.
Nov 2027was Oct 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 29, 2026
Sites
5 sites added — first sites in Australia and South Africa. Research Facility is now Recruiting
Show 5 added (3 Australia, 2 South Africa)
  • Research Facility · St Leonards, Australia
  • Research Facility · Nedlands, Australia
  • Research Facility · Perth, Australia
  • Research Facility · Johannesburg, South Africa
  • Research Facility · Pretoria, South Africa
across 2 updates, Sep 29, 2026 – Oct 13, 2026
Primary completion
Jul 2027→Aug 2027
Sep 29, 2026
Study completion
Oct 2027→Nov 2027
Sep 29, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Research Facility · Christchurch, New ZealandContact removed (no phone or email listed)
Sep 29, 2026
Show all 2 updates
  1. Oct 13, 2026
    2 sites added — first site in South Africa
    Show 2 added (2 South Africa)
    • Research Facility · Johannesburg, South Africa
    • Research Facility · Pretoria, South Africa
    + 1 other change: verification date
  2. Sep 29, 2026
    Not yet recruiting→Recruiting
    3 sites added — first site in Australia. Research Facility is now Recruiting
    Show 3 added (3 Australia)
    • Research Facility · St Leonards, Australia
    • Research Facility · Nedlands, Australia
    • Research Facility · Perth, Australia
    Primary completion Jul 2027→Aug 2027
    Study completion Oct 2027→Nov 2027
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Research Facility · Christchurch, New ZealandContact removed (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

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
Oct 13, 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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