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NCT Number: NCT07671092

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

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.

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Key information

Conditions

Metastatic Urothelial Carcinoma Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Hormone Receptor Positive HER-2 Negative Breast Cancer Lung Diseases Lung Neoplasms NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases TNBC - Triple-Negative Breast Cancer Thoracic Neoplasms Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Facility

Christchurch, New Zealand

Location contact

Site Contact

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RYZ211/212

Diagnostic Test

Imaging Agent

Primary outcomes

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

    Time frame: 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

  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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

RayzeBio Clinical Trials

CONTACT

[email protected]

(619) 657-0057

Sponsors and collaborators

Lead sponsor

RayzeBio, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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