Imaging Study in Metastatic Clear Cell RCC.

Early Phase 1Not Yet RecruitingNCT07671417

RayzeBio, Inc.10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Interventions

RYZ512DIAGNOSTIC_TEST

Imaging Agent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Facility

Christchurch, New Zealand

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Study duration (6 months)

Central Contacts

RayzeBio Clinical Trials

CONTACT

(619) 657-0057 clinicaltrials@rayzebio.com

Data from ClinicalTrials.gov

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