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RYZ211/212

Phase 1

Metastatic Urothelial Carcinoma | Unknown | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 26, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

RYZ211/212 · 1 trial · 5 indications

Early Phase 1 1
NCT07671092Imaging Study of a TROP2 Binder in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLCMetastatic Urothelial Carcinoma
NOT YET_RECRUITING40 Analytics
EARLY_PHASE1NOT YET_RECRUITING
Imaging Study of a TROP2 Binder in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
Metastatic Urothelial CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the biodistribution of RYZ211 (68Ga-RAYZ-2453) in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC
Study duration (1 year)

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

To evaluate the long biodistribution and radiation absorbed doses in critical organs and tumors, and the effective dose of RYZ212 (177Lu-RAYZ-2453) in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC
Study duration (1 year)

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)

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
RYZ211/212EXPERIMENTAL -

Interventions

NameTypeDescription
RYZ211/212DIAGNOSTIC_TESTImaging Agent
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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: * TROP2-targeting antibody-drug conjugates (ADCs) such as sacituzumab govitecan or datopotamab...

Countries:New Zealand
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Frequently asked questions about RYZ211/212

What is RYZ211/212 used for?

RYZ211/212 is an investigational imaging agent being studied in metastatic urothelial carcinoma, as well as in hormone receptor positive HER2 negative breast cancer, triple-negative breast cancer, and non-small cell lung cancer. It is a TROP2 binder intended for use in imaging studies.

Who is developing RYZ211/212?

RYZ211/212 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting a Phase 1 clinical trial to evaluate the drug as an imaging agent in multiple cancer types.

What does RYZ211/212 target?

RYZ211/212 targets TROP2, a protein commonly expressed in various solid tumors. As a TROP2 binder, it is designed to bind to this target for imaging purposes, potentially enabling visualization of tumors that express TROP2.

What phase is RYZ211/212 in?

RYZ211/212 is in Phase 1 clinical development. The ongoing trial is an early Phase 1 study, and the drug is investigational, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials.

What clinical trials is RYZ211/212 in?

RYZ211/212 is being studied in a single clinical trial with the identifier NCT07671092. This early Phase 1 imaging study is enrolling 40 participants with metastatic urothelial carcinoma, breast cancer subtypes, and non-small cell lung cancer, and is being conducted in New Zealand.