Clinical trial Recruiting at 4 sites Early Phase 1 Interventional Ages 18 and up

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.

More Breast Cancer trials

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorRayzeBio, Inc.
Industry-sponsored
Locations6 sites (St Leonards, New South Wales and 5 other locations)
StatusRecruiting
StartedJune 15, 2026
Main results expectedAugust 2027
Study endsNovember 2027
Registry record updatedOctober 13, 2026
Trial IDNCT07671092 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.