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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 2, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Prostate Cancer SurgeryProstate Cancer Metastatic Disease
Interventions
DRUG

0.03mg/kg ZOPOCIANINE given day of surgery

A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

DRUG

0.06mg/kg ZOPOCIANINE given day of surgery

A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

DRUG

0.03mg/kg ZOPOCIANINE given day prior to surgery

A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

DRUG

0.06mg/kg ZOPOCIANINE given days prior to surgery

A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

Trial Locations (3)

46032

RECRUITING

Indiana University Health North Hospital, Carmel

46202

RECRUITING

Indiana University Health Methodist Hospital, Indianapolis

RECRUITING

Indiana University School of Medicine, Indianapolis

Sponsors
All Listed Sponsors
collaborator

Indiana University Melvin and Bren Simon Cancer Center

OTHER

collaborator

On Target Laboratories, LLC

INDUSTRY

lead

Clinton Bahler

OTHER

NCT06849544 - Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection | Biotech Hunter | Biotech Hunter