Imaging Study in Metastatic Clear Cell RCC.

A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of the Imaging Agent in Subjects With Metastatic Clear Cell Renal Cell Cancer (RCC).

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07671417

Enrollment

Registered

2026-06-26

Start date

2026-06-01

Completion date

2027-01-01

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

Metastatic Clear Cell Renal Cell Carcinoma

Keywords

RCC, Metastatic RCC, Metastatic Clear Cell Renal Cancer, 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 Clear Cell Renal Cell Cancer (RCC).

Interventions

DIAGNOSTIC_TESTRYZ512

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

* At least 18 years old at the time of signing the informed consent form (ICF). * Biopsy proven metastatic clear cell renal cell carcinoma (RCC)

Exclusion criteria

* Subjects taking below mentioned medications that cannot be stopped 5 half-lives prior to RYZ512 administration and cannot be restarted until all study-related imaging is completed: Anticonvulsants, Antipsychotics, Carbonic Anhydrase inhibitors, COX-2 Inhibitors, Sulfatase Inhibitors, Sulfonamides * Women of Childbearing Potential that 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 assess the tolerability of the imaging agent subjects with metastatic clear cell RCC.	Study duration (6 months)	To assess the tolerability of RYZ512 by monitoring incidence and severity of AEs by NCI CTCAE v5, including SAEs, and other safety findings in subjects with metastatic clear cell RCC.
To evaluate the (long) biodistribution of RYZ512 in subjects with metastatic clear cell RCC.	Study duration (6 months)	To evaluate the (long) biodistribution of RYZ512 by using visual assessment of location, extent, and intensity of RYZ512 uptake in critical organs and tumors in subjects with metastatic clear cell RCC.
To evaluate the radiation absorbed doses of RYZ512 in critical organs and tumors as well as the effective dose in subjects with metastatic clear cell RCC.	Study duration (6 months)	To evaluate the radiation absorbed doses of RYZ512 using calculated mean TIAC (MBq·hr/MBq), radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to critical organs (e.g., stomach, liver, kidneys, bone marrow), calculated mean TIAC (MBq·hr/MBq) and radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to tumors, calculated whole-body effective dose (mSv/MBq) in critical organs and tumors as well as the effective dose in subjects with metastatic clear cell RCC.

Countries

New Zealand

Contacts

CONTACTRayzeBio Clinical Trials

clinicaltrials@rayzebio.com(619) 657-0057

STUDY_DIRECTORFreddy Escorcia, MD, PhD

RayzeBio, Inc.

STUDY_DIRECTORHeying Duan, MD