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

Trial status:Recruiting
Trial ID:
PRESERVE-006
NCT ID:
NCT05682443
EudraCT ID:
N/A
EU Trial (CTIS) Number:
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.
Collaborator:
Prostate Cancer Clinical Trials Consortium
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
    • Study Drug
  • ONC-392 low
    • See more
  • ONC-392 high
  • lutetium Lu 177 vipivotide tetraxetan
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    141
    Estimated Trial Date
    Dec 2023 - Jun 2026

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Inclusion Criteria:

    1. Patients must be ≥ 18 years of age and have the ability to understand and sign an approved informed consent form (ICF).
    2. Patients must have an ECOG performance status of 0 or 1.
    3. Patients must have a life expectancy \> 6 months.
    4. Patients must have histological or cytological confirmation of prostate adenocarcinoma.
    5. Patients must have a positive PSMA in an FDA-approved PSMA PET scan. A positive PSMA is defined as at least one tumor lesion with PSMA uptake greater than normal liver.
    6. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
    7. Patients must have received at least one second generation AR-targeting agents (such as apalutamide, darolutamide, enzalutamide and/or abiraterone).
    8. Patients should have prior treatment of up to two taxane regimens, or are unfit for, or refuse taxane chemotherapy. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Note: Taxane chemotherapy administered in the Castration Sensitive Prostate Cancer (CSPC) or Castration Resistant Prostate Cancer (CRPC) setting is allowed.
    9. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
      1. Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 1.0 ng/mL.
      2. RECIST v1.1 soft-tissue progression
      3. Progression of bone disease: 2 or more new metastatic bone lesions by bone scan per PCWG3 criteria.
    10. Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤ 42 days prior to beginning study therapy.
    11. Patients must have adequate organ function.
    12. Patients with or without concomitant bisphosphonate or denosumab regimen for ≥ 30 days prior to randomization are eligible.
    13. For patients who have partners of childbearing potential: Partner and/or patient must use adequate methods of birth control with barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration.

      14. Exclusion Criteria:

    14. 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.
    15. 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.
    16. Known hypersensitivity to the components of the study therapy or its analogs.
    17. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
    18. Transfusion within 14 days of first day of study treatment
    19. 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.
    20. 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.
    21. 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).
    22. A superscan as seen in the baseline bone scan.
    23. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
    24. 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.
    25. Active concurrent malignancy (with the exception of non-melanomatous skin cancer). Patients with carcinoma in situ of any origin and patients with prior malignancies who are in remission and/or whose likelihood of recurrence is very low per investigator's judgment are eligible for this study.
    26. Receiving systemic steroid therapy with \> 10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication.
    27. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
    28. Active or previously documented autoimmune disease and/or current use of immunosuppressive agents. Use of endocrine replacement therapy (e.g., thyroxine, insulin, low dose of steroid, etc.) is allowed.

    Trial Locations

    Location
    Status
    Location
    UC Davis Comprehensive Cancer Center
    Sacramento, California, United States, 95817
    Status
    Recruiting
    Location
    Rocky Mountain Cancer Centers USOR
    Aurora, Colorado, United States, 80012
    Status
    Recruiting
    Location
    Moffitt Cancer Cancer
    Tampa, Florida, United States, 33612
    Status
    Recruiting
    Location
    Emory University Winship Cancer Institute
    Atlanta, Georgia, United States, 30322
    Status
    Recruiting
    Location
    The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland, United States, 21202
    Status
    Recruiting
    Location
    Chesapeake Urology Research Associates
    Towson, Maryland, United States, 21204
    Status
    Recruiting
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