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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRayzeBio, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

For Women of Childbearing Potential: Are pregnant or breastfeeding

Trial design

Design model

Single group

Treatments tested in this trial

  • RYZ211/212

    Diagnostic test

    Imaging Agent

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: RYZ211/212Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Study duration (1 year)
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

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)

Time frame
Study duration (1 year)

Secondary outcomes

Other outcomes

Sponsors and contacts

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