A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy

Study Overview
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Brief Summary
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This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.

Official Title
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A Phase 1 Safety and Efficacy Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: IS-002


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between the ages of 18 and 75. Subject has a confirmed adenocarcinoma by histology of the prostate. Subject has CAPRA > 6, or T3 a or b disease on imaging (TRUS and/or MRI), or regional lymphadenopathy suspicious for nodal metastases Subject is scheduled to undergo robotic prostatectomy with extended pelvic lymph node dissection (ePLND) using an da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging. Subject is willing and able to provide informed consent Subject is considered capable of complying with study procedures and of understanding a written informed consent document. Subject must be treatment naïve (not having received neo-adjuvant therapy, radiation therapy, hormonal therapy, androgen deprivation therapy within the last 4 months excluding Finasteride, Dutasteride, or other 5 alpha reductase inhibitors, or focal ablation techniques) Exclusion Criteria: Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Subject is currently participating in and receiving study therapy or has participated in a study of an investigational agent within the past 6 months; is receiving study therapy or is involved in a significant risk investigational device study within the past 6 months Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile Subject has a known history of bone metastasis documented on the basis of bone scans and/or biopsy Subject has a known history of acute or chronic liver or kidney disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation<br>Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels | Drug: IS-002<br>* Intravenous injection of IS-002 Investigational Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 | Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IS-002 Maximum Plasma Concentration (Cmax) | Maximum Plasma Concentration (Cmax) of IS-002 | -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours | 
| IS-002 Half-Life (t½) | Half-Life (t½) of IS-002 | -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours | 
| IS-002 Clearance (CL) | Clearance (CL) of IS-002 | -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours | 
| IS-002 Area Under the Plasma Concentration Versus Time Curve (AUC) | Area Under the Plasma Concentration Versus Time Curve (AUC) of IS-002 | -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours |