Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Clinton Bahler
Study ID
NCT06849544
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Prostate Cancer Metastatic Disease
  • Prostate Cancer Surgery

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 0.03mg/kg ZOPOCIANINE given day of surgery — DRUG
    A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
  • 0.06mg/kg ZOPOCIANINE given day of surgery — DRUG
    A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
  • 0.03mg/kg ZOPOCIANINE given day prior to surgery — DRUG
    A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
  • 0.06mg/kg ZOPOCIANINE given days prior to surgery — DRUG
    A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

Study Details

This study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Key Dates

Start date
Apr 2, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 0.03mg/kg ZOPOCIANINE given day of surgery
    A single dose of 0.03mg/kg ZOPOCIANINE (given 1 - 12 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
  • Experimental: 0.06mg/kg ZOPOCIANINE given day prior to surgery
    A single dose of 0.06mg/kg ZOPOCIANINE (given 12 - 30 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
  • Experimental: 0.03mg/kg ZOPOCIANINE given day prior to surgery
    A single dose of 0.03mg/kg ZOPOCIANINE (given 12 - 30 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
  • Experimental: 0.06mg/kg ZOPOCIANINE given 2-7 days prior to surgery
    A single dose of 0.06mg/kg ZOPOCIANINE (given 2-7 days prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Primary Outcome Measure

Porportion of subjects who have a Clinically Significant Event [ Time Frame: Day of surgery ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana University Health North HospitalCarmelIndiana46032
Ashley Frazee
[email protected]
317-948-9575
Clinton Bahler, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Health Methodist HospitalIndianapolisIndiana46202
Ashley Frazee
[email protected]
317-948-9575
Clinton Bahler, MD (PRINCIPAL_INVESTIGATOR)
Indiana University School of MedicineIndianapolisIndiana46202
Ashley Frazee
[email protected]
317-948-9575
Clinton Bahler, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University Health North Hospital· Carmel, INIndiana University Health Methodist Hospital· Indianapolis, INIndiana University School of Medicine· Indianapolis, IN

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