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

NCT06849544 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UROL-CC-IUSCCC-0902
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Prostate Cancer Surgery; Prostate Cancer Metastatic Disease

Keywords

Prostate Specific Membrane Antigen; Fluorescent Imaging; Near infrared imaging

Outcome Measures

Primary Outcomes (1)

• Porportion of subjects who have a Clinically Significant Event

  1. Histologically confirmed cancer in residual non-nodal soft tissue resected solely because of "NIR only" detection as suspicious following prostatectomy. 2. One or more resected NIR- positive lymph nodes that contain metastatic disease as confirmed by pathology.

  Day of surgery

Secondary Outcomes (4)

• Detection of Primary cancer

  Day of surgery

• Detection of Metastatic Cancer

  Day of surgery

• Execution of pre-surgery plan

  Day of surgery

• Safety and tolerability of ZOPOCIANINE

  Screening to 6 week follow-up

Other Outcomes (1)

• Cancer detected by NIR only

  Day of Surgery

Study Arms (4)

0.03mg/kg ZOPOCIANINE given day of surgery

EXPERIMENTAL

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.

Drug: 0.03mg/kg ZOPOCIANINE given day of surgery

0.06mg/kg ZOPOCIANINE given day prior to surgery

EXPERIMENTAL

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.

Drug: 0.06mg/kg ZOPOCIANINE given day of surgery

0.03mg/kg ZOPOCIANINE given day prior to surgery

EXPERIMENTAL

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.

Drug: 0.03mg/kg ZOPOCIANINE given day prior to surgery

0.06mg/kg ZOPOCIANINE given 2-7 days prior to surgery

EXPERIMENTAL

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.

Drug: 0.06mg/kg ZOPOCIANINE given days prior to surgery

Interventions

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

0.06mg/kg ZOPOCIANINE given day prior to surgery

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

0.03mg/kg ZOPOCIANINE given day prior to surgery

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

0.03mg/kg ZOPOCIANINE given day of surgery

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

0.06mg/kg ZOPOCIANINE given 2-7 days prior to surgery

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent and HIPAA form
• Male subjects 18 years of age and older
• Known primary prostate cancer and Grade Group 3 to 5 (≥ cT3) or one or more of the following:
• Suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)),
• or more biopsy cores of grade group 3-5;
• Suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));
• Planned to undergo a standard of care robotic prostatectomy and lymph node dissection
• Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
• Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.

You may not qualify if:

• The surgeon plans to perform an extraperitoneal approach
• History of anaphylactic reactions to products containing indocyanine green
• History of allergy to any of the components of ZOPOCIANINE:
• \[3-(1,3-dicarboxypropyl)ureido\] pentanedioic acid (DUPA)
• Polyethylene glycol-dipeptide linker
• Chlorodye
• Impaired renal or hepatic function:
• Renal: creatinine clearance (eGFR) \< 50 mL/min
• Hepatic: total bilirubin \> 2 × upper limit of normal or ALT/AST \> 3 × upper limit of normal.
• Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening.
• Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Sponsors & Collaborators

• On Target Laboratories, LLC: collaborator
• Indiana University: collaborator
• Clinton Bahler: lead

Study Sites (3)

Indiana University Health North Hospital

Carmel, Indiana, 46032, United States

RECRUITING

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Study Officials

• Clint Bahler, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Frazee, PhD

CONTACT

317-948-9575; amfrazee@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)