Imaging Test for Metastatic Urothelial and Breast C cancers and NSCLC
Official 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)
Run by RayzeBio, Inc. · NCT07671092 · Data updated 2026-11-12
This imaging study tests how well the imaging agent works in people with metastatic urothelial cancer, various breast cancers, or NSCLC.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | RayzeBio, Inc. Industry-sponsored |
| Locations | 6 sites (St Leonards, New South Wales and 5 other locations) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | August 2027 |
| Study ends | November 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07671092 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with biopsy-proven metastatic urothelial carcinoma, HR-positive/HER2-negative breast cancer, triple-negative breast cancer, or NSCLC.
✕Probably not a fit
Participants who have cancers not expressing targets detectable by the imaging agent or who cannot tolerate imaging procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early phase, first-in-human imaging study evaluates the feasibility, distribution in the body, and dosimetry of an imaging agent in adults with metastatic urothelial carcinoma, HR-positive/HER2-negative breast cancer, triple-negative breast cancer, or non–small cell lung cancer. Participants receive the imaging agent and undergo imaging procedures to measure uptake and exposure. The study is conducted at selected research facilities and is sponsored by RayzeBio, with sites in Australia. Eligibility includes adults with biopsy-confirmed metastatic disease and nonpregnant status for those who could become pregnant, with site-specific inclusion criteria to be reviewed at enrollment.
Why it matters
Potential benefit: If successful, participants may contribute to determining how well the imaging agent reveals cancer sites and supports future diagnostic approaches.
How similar studies have gone: Previous imaging agent studies in cancer patients have shown potential for localization and dosimetry, though this specific agent is being evaluated in an early-phase setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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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 -
Research Facility
Pretoria, South Africa Active not recruiting
Study contacts
- Study coordinator: RayzeBio Clinical Trials
- Email: clinicaltrials@rayzebio.com
- Phone: (619) 657-0057
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.