Safety and Efficacy of OTL78 (Zopocianine)

NCT07725523 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UROL-CC-IUSCCC-0965
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being done to support the selection of single dose and timing regimen of Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients 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)

• Proportion of subjects who have a Clinically Significant Event

  a) Histologically confirmed cancer in residual non-nodal soft tissue resected solely because of "NIR only" detection as suspicious following prostatectomy. b) 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

• Incidence rates AEs and all SAEs

  Screening to 6 week follow-up

Study Arms (1)

0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery

EXPERIMENTAL

A single dose of 0.06mg/kg ZOPOCIANINE (given 1-7 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 1-7 days prior to surgery

Interventions

0.06mg/kg ZOPOCIANINE given 1-7 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 1-7 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 participants 18 years of age and older
• Known primary prostate cancer and any one of the following:
• Grade group 3-5;
• Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);
• Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography
• 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.
• Patient scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.

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 calculated via the Bazett formula.
• Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, and/or compromise the objectives of the study.

Sponsors & Collaborators

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

Study Sites (2)

Indiana University Health North Hospital

Carmel, Indiana, 46032, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Clint Bahler, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon Garver

CONTACT

317-278-4766; brwgarve@iu.edu

Study Design

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

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (2)