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Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    Male
  • 网红黑料y Volunteers
    No
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Objective

A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

Description

A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

Details

Full study title A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Protocol number OCR46886
ClinicalTrials.gov ID NCT06450106
Phase Phase 1

Eligibility

Inclusion Criteria:

  1. Males aged 18 years or older at time of informed consent.

  2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.

  3. Grade Group 2-5.

  4. Eastern Cooperative Oncology Group (ECOG) Performance Status 鈮�2 at Screening.

  5. Have adequate organ and bone marrow function at screening.

  6. Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document

Exclusion Criteria:

  1. Have an invasive malignancy, other than the disease under study.

  2. Anticipated to require the use of a drain after radical prostatectomy.

  3. Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days.

  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate.

  5. History of allogeneic organ transplant.

  6. History of primary immunodeficiency.

  7. QTc interval >470 msec at Screening.

Lead researcher

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  1. Step
    1

    Contact the research team

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  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
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    Participate

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