🏛️ Verified NIH Record • Updated 2026-05-20

ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (NCT05682443)

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: OncoC4, Inc.

🩺 Plain-English Summary (8th-Grade Level)

In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (16 items).

Location: UC Davis Comprehensive Cancer Center — Sacramento, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to prior cancer therapeutics except neuropathy or endocrinopathy with Gr 2 or less.
  • Any systemic anti-cancer therapy within 5 half-lives or 14 days, whichever is shorter (small molecule drugs) or within 28 days for antibody based therapy, prior to starting study treatment.
  • Known hypersensitivity to the components of the study therapy or its analogs.
  • Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
  • Transfusion within 14 days of first day of study treatment
  • PSMA-negative lesions are defined as lesions with PSMA uptake equal to or lower than that of liver parenchyma. Patients with PSMA-negative lesions in any lymph node with a short axis of ≥ 2.5 cm, in any metastatic solid-organ lesions with a short axis of ≥ 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of ≥ 1.0 cm in the short axis are ineligible.
  • Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to randomization. Previous PSMA-targeted radioligand therapy is not allowed.
  • Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
  • A superscan as seen in the baseline bone scan.
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, myocardial infarction within 6 months, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, or unstable arrhythmia within 3 months, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (23 Sites)

  • UC Davis Comprehensive Cancer Center — Sacramento, California
  • Rocky Mountain Cancer Centers USOR — Aurora, Colorado
  • Moffitt Cancer Cancer — Tampa, Florida
  • Emory University Winship Cancer Institute — Atlanta, Georgia
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland
  • Chesapeake Urology Research Associates — Towson, Maryland
  • Lahey Hospital & Medical Center — Burlington, Massachusetts
  • University of Mississippi Medical Center — Jackson, Mississippi
  • XCancer/GU Research Network — Omaha, Nebraska
  • Rutgers Cancer Institute — New Brunswick, New Jersey
  • New Mexico Oncology Hematology Consultants — Albuquerque, New Mexico
  • Roswell Park Comprehensive Cancer Center — Buffalo, New York
  • NYU Langone Health, Laura & Isaac Perlmutter Cancer Center — New York, New York
  • Columbia University Irving Cancer Center — New York, New York
  • UNC North Carolina Comprehensive Cancer Care Center — Chapel Hill, North Carolina
  • Duke Cancer Center — Durham, North Carolina
  • The Ohio State University Comprehensive Cancer Center — Columbus, Ohio
  • OHSU Knight Cancer Institute — Portland, Oregon
  • UT Southwestern Medical Center — Dallas, Texas
  • Virginia Cancer Specialists USOR — Fairfax, Virginia
  • Virginia Oncology Associates USOR — Norfolk, Virginia
  • Oncology and Hematology Associates Of Southwest Virginia USOR — Norton, Virginia
  • UW Carbone Cancer Center — Madison, Wisconsin

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗