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RYZ711 Diagnostic Platform Study

ConditionsProstate Cancer (Adenocarcinoma)Adenocarcinoma of the ProstateMetastatic Castration-resistant Prostate Cancer (mCRPC)Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Biochemical Recurrence (BCR)High-Risk Localized Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorRayzeBio, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed adenocarcinoma of the prostate

ECOG PS ≤ 2

Planned or scheduled PSMA PET/CT scan

Cohort 1: Unfavorable intermediate-risk or higher per NCCN 2026 guidelines, with planned RP and extended PLND within 6 weeks of RYZ711 PET/CT

Disqualifiers

eGFR < 60 mL/min, QTcF > 470 ms, impaired hepatic function

Neuroendocrine, sarcomatoid, or spindle cell prostate cancer

Non-prostate metastatic malignancy

Cohort 1: Any prior prostate cancer therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • RYZ711

    Drug

    RYZ711 PET/CT; PSMA PET/CT

  • PSMA PET/CT

    Diagnostic test

    RYZ711 PET/CT; PSMA PET/CT

Treatment groups

116 Participants
are divided into 3 treatment groups
Group A: Cohort 1 - RYZ711Experimental treatment 2 interventions
Group B: Cohort 2 - RYZ711Experimental treatment 2 interventions
Group C: Cohort 3 - RYZ711Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of AEs, SAEs, and Adverse Events of Special Interest (AESIs)

Incidence of AEs, SAEs, and AESIs including changes in vital signs, clinical laboratory evaluations, 12-lead ECG, and other safety findings

Time frame
From informed consent up to 3 months post-RYZ711 PET/CT
2

Concordance Rate of RYZ711 PET/CT Compared with PSMA 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

Time frame
Up to 3 months post-RYZ711 PET/CT

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RayzeBio, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: