Clinical Trial · NCT07862582

RYZ711 Diagnostic Platform Study

Overview

This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed adenocarcinoma of the prostate.

Sponsor

RayzeBio, Inc.

Phase

Phase 1/2

Contacts

RayzeBio Clinical Trials (CONTACT)

clinicaltrials@rayzebio.com

+1 619 657 0057

Anthony A Golsorkhi, MD, Study Director, RayzeBio, Inc, MD Study Director (CONTACT)

ClinicalTrials.gov

NCT07862582

Eligibility

Inclusion

eGFR \< 60 mL/min, QTcF \> 470 ms, impaired hepatic function
Inclusion CriteriaSubjects who meet all of the following criteria are eligible for inclusion in the study:
Cohort 3: mHSPC or mCRPC with documented disease progression; candidate for PSMA-targeted radiopharmaceutical therapyExclusion CriteriaSubjects who meet any of the following criteria will be excluded from the study:
Cohort 1: Unfavorable intermediate-risk or higher per NCCN 2026 guidelines, with planned RP and extended PLND within 6 weeks of RYZ711 PET/CT
Neuroendocrine, sarcomatoid, or spindle cell prostate cancer
Cohort 1: Any prior prostate cancer therapy
Cohort 2: Rising PSA after definitive therapy meeting standard BCR criteria (AUA 2026 or Phoenix criteria)
Cohort 3: Prior ¹⁷⁷Lu-PSMA therapy within 6 weeks of PSMA PET/CT
ECOG PS ≤ 2
Planned or scheduled PSMA PET/CT scan
Non-prostate metastatic malignancy
Cohort 2: Ongoing or recent ADT (within 3 months prior to Day 1)
Histologically confirmed adenocarcinoma of the prostate

Exclusion

Exclusion criteria not yet provided.