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

Trial status:Recruiting
Trial ID:
PRESERVE-006
NCT ID:
EudraCT ID:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
OncoC4, Inc.
Recruiting

Trial Details

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.

Medical Condition
  • Prostate Cancer
  • Trial Drug
  • ONC-392
  • See more
  • lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses.
  • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    144
    Estimated Trial Date
    Dec 2023 - Jun 2026

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    University of California at Davis Cancer Center - 1624
    Davis, California, United States, 95817
    Status
    Recruiting
    Location
    Rocky Mountain Cancer Center USOR - 1633
    Aurora, Colorado, United States, 80012
    Status
    Recruiting
    Location
    Moffitt Cancer Cancer- 1605
    Tampa, Florida, United States, 33612
    Status
    Recruiting
    Location
    Johns Hopkins University Medical Center - 1627
    Baltimore, Maryland, United States, 21202
    Status
    Recruiting
    Location
    Chesapeake Urology Research Associates - 1609
    Towson, Maryland, United States, 21204
    Status
    Recruiting
    Location
    Lahey Hospital and Medical Center - 1626
    Burlington, Massachusetts, United States, 01805
    Status
    Recruiting