Zopocianine for Cancer Detection

Overseen By Ashley Frazee, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Clinton Bahler

Disqualifiers: Renal impairment, Hepatic impairment, QTc prolongation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Day of surgery

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment OTL78 Injection for cancer detection?

Research on similar treatments, like near-infrared photoimmunotherapy (NIR-PIT), shows that using a dye linked to an antibody can help detect and treat cancer by targeting specific cancer cells with light, leading to their destruction. This approach has been effective in clinical trials for other cancers, suggesting potential for OTL78 Injection in cancer detection. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Clint Bahler, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults with biopsy-confirmed prostate cancer who are scheduled for a prostatectomy and lymph node dissection. Specific eligibility details aren't provided, but typically participants must be in good health aside from their cancer and meet certain criteria set by the study.

Inclusion Criteria

Provision of signed and dated informed consent and HIPAA form

I am a man aged 18 or older.

Agree to use a medically acceptable method of birth control or sexual abstinence for the duration of the study

Exclusion Criteria

History of allergy to specific components of ZOPOCIANINE

Patients with QTc interval ≥ 470 msec per ECG at screening

I do not have any serious health issues that could make the trial unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ZOPOCIANINE with NIR fluorescent imaging during prostatectomy and lymph node dissection

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• OTL78 Injection

Trial Overview The trial tests three different doses of Zopocianine (OTL78) given at varying times around surgery day to see if it helps better detect cancerous tissue when used with NIR fluorescent imaging during prostate removal surgeries.

Participant Groups

Group I: 0.06mg/kg ZOPOCIANINE given day prior to surgery Experimental Treatment 1 Intervention

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.

Group II: 0.06mg/kg ZOPOCIANINE given 2-7 days prior to surgery Experimental Treatment 1 Intervention

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.

Group III: 0.03mg/kg ZOPOCIANINE given day prior to surgery Experimental Treatment 1 Intervention

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.

Group IV: 0.03mg/kg ZOPOCIANINE given day of surgery Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Clinton Bahler

Lead Sponsor

Trials

3

Recruited

80+

Indiana University Melvin and Bren Simon Cancer Center

Collaborator

Trials

7

Recruited

700+

On Target Laboratories, LLC

Industry Sponsor

Trials

8

Recruited

470+

References

1. England pubmed.ncbi.nlm.nih.gov

Resection guided by antibodies (REGAJ): a diagnostic procedure during second-look operation in ovarian cancer patients. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Role of In-111 labeled CYT-103 immunoscintigraphy in the evaluation of patients with recurrent colorectal carcinoma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Near-Infrared Photoimmunotherapy of Cancer. [2020]

4. France pubmed.ncbi.nlm.nih.gov

[Cancer immunophotodetection and immunophototherapy]. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Clinical implications for immunoscintigraphy in patients with ovarian malignancy: a preliminary study using monoclonal antibody 791T/36. [2019]