Imaging Study in Metastatic Clear Cell RCC.

NCT07671417 | Not Yet Recruiting Early Phase 1

• 1 other identifier: RYZ512-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (3)

• To assess the tolerability of the imaging agent subjects with metastatic clear cell RCC.

  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.

  Study duration (6 months)

• To evaluate the (long) biodistribution of RYZ512 in subjects with metastatic clear cell RCC.

  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.

  Study duration (6 months)

• 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.

  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.

  Study duration (6 months)

Study Arms (1)

Imaging Study in Metastatic Clear Cell RCC.

EXPERIMENTAL

Diagnostic Test: RYZ512

Interventions

RYZ512 DIAGNOSTIC_TEST

Imaging Agent

Imaging Study in Metastatic Clear Cell RCC.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RayzeBio, Inc.: lead

Study Sites (1)

Research Facility

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma

Study Officials

• Freddy Escorcia, MD, PhD

  RayzeBio, Inc.

  STUDY DIRECTOR

• Heying Duan, MD

  RayzeBio, Inc.

  STUDY DIRECTOR

Central Study Contacts

RayzeBio Clinical Trials

CONTACT

(619) 657-0057; clinicaltrials@rayzebio.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

NZ (1)