RYZ711 Diagnostic Platform Study

November 9, 2026 updated by: RayzeBio, Inc.

Phase 1 /2 Multicenter, Basket, Imaging Study Investigating the Safety and Diagnostic Performance of RYZ711 in Men With Prostate Cancer.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Anthony A Golsorkhi, MD, Study Director, RayzeBio, Inc, MD Study Director

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

Subjects who meet all of the following criteria are eligible for inclusion in the study:

  1. Histologically confirmed adenocarcinoma of the prostate
  2. ECOG PS ≤ 2
  3. Planned or scheduled PSMA PET/CT scan
  4. Cohort 1: Unfavorable intermediate-risk or higher per NCCN 2026 guidelines, with planned RP and extended PLND within 6 weeks of RYZ711 PET/CT
  5. Cohort 2: Rising PSA after definitive therapy meeting standard BCR criteria (AUA 2026 or Phoenix criteria)
  6. Cohort 3: mHSPC or mCRPC with documented disease progression; candidate for PSMA-targeted radiopharmaceutical therapy

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

  1. eGFR < 60 mL/min, QTcF > 470 ms, impaired hepatic function
  2. Neuroendocrine, sarcomatoid, or spindle cell prostate cancer
  3. Non-prostate metastatic malignancy
  4. Cohort 1: Any prior prostate cancer therapy
  5. Cohort 2: Ongoing or recent ADT (within 3 months prior to Day 1)
  6. Cohort 3: Prior ¹⁷⁷Lu-PSMA therapy within 6 weeks of PSMA PET/CT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - RYZ711

High-risk localized prostate cancer planned for RP/PLND
Drug: RYZ711

RYZ711 PET/CT; PSMA PET/CT

Diagnostic test: PSMA PET/CT

RYZ711 PET/CT; PSMA PET/CT
Experimental: Cohort 2 - RYZ711

Biochemical recurrence after definitive therapy
Drug: RYZ711

RYZ711 PET/CT; PSMA PET/CT

Diagnostic test: PSMA PET/CT

RYZ711 PET/CT; PSMA PET/CT
Experimental: Cohort 3 - RYZ711

Metastatic disease (mHSPC or mCRPC)
Drug: RYZ711

RYZ711 PET/CT; PSMA PET/CT

Diagnostic test: PSMA PET/CT

RYZ711 PET/CT; PSMA PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of AEs, SAEs, and Adverse Events of Special Interest (AESIs)
Time Frame: From informed consent up to 3 months post-RYZ711 PET/CT

Incidence of AEs, SAEs, and AESIs including changes in vital signs, clinical laboratory evaluations, 12-lead ECG, and other safety findings
From informed consent up to 3 months post-RYZ711 PET/CT
Concordance Rate of RYZ711 PET/CT Compared with PSMA PET/CT
Time Frame: Up to 3 months post-RYZ711 PET/CT

The concordance rate is defined as the proportion of subjects with per-region correspondence of at least 1 lesion identified on RYZ711 PET/CT and PSMA PET/CT
Up to 3 months post-RYZ711 PET/CT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RayzeBio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 1, 2026

First Submitted That Met QC Criteria

October 1, 2026

First Posted (Actual)

October 7, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 9, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RYZ711-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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