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Clinical Trials in the USA / NCT07862582
Starting soon Phase 1/2

RYZ711 Diagnostic Platform Study

NCT07862582 · tracked via the Priya Life Science USA tracker
Sponsor
RayzeBio, Inc
Phase
Phase 1/2
Started
2026-10
Last updated
2026-10-19

Condition(s) studied

Prostate 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

Investigational drug(s) / intervention(s)

RYZ711PSMA PET/CT

RYZ711: RYZ711 PET/CT; PSMA PET/CT

PSMA PET/CT: RYZ711 PET/CT; PSMA PET/CT

Study summary

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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of AEs, SAEs, and Adverse Events of Special Interest (AESIs) — 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
  • Concordance Rate of RYZ711 PET/CT Compared with PSMA PET/CT — 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

Trial sites (1)

FacilityCityRegionStatus
Research Facility Omaha Nebraska

More RayzeBio, Inc. trials in the USA

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs. Recruiting
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC Active, not recruiting
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy Active, not recruiting
Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC Recruiting
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs. Recruiting

Other trials for the same condition

A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Recruiting
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec Recruiting
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05) Recruiting
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function Active, not recruiting
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07862582 on ClinicalTrials.gov ↗ ← All trials in the USA