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

A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of the Imaging Agent in Metastatic Urothelial Cancer (UC), Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Breast Cancer, Triple-Negative Breast Cancer (TNBC), and Non-Small-Cell Lung Cancer (NSCLC)

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07671092

Enrollment

Registered

2026-06-26

Start date

2026-06-01

Completion date

2027-10-01

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HR+, HER2-, Breast Cancer, Non Small Cell Lung Cancer, Triple Negative Breast Cancer, TNBC, RayzeBio, Rayze, BMS, Bristol Myers Squibb, RPT, Imaging Agent

Brief 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.

Interventions

DIAGNOSTIC_TESTRYZ211/212

Imaging Agent

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

* For Women of Childbearing Potential: Are pregnant or breastfeeding Note: Additional criteria may apply and will be assessed by the study site

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the biodistribution of RYZ211 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 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)

Countries

New Zealand

Contacts

CONTACTRayzeBio Clinical Trials

clinicaltrials@rayzebio.com(619) 657-0057

STUDY_DIRECTORFreddy Escorcia

RayzeBio, Inc.

STUDY_DIRECTORHeying Duan