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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: IS-002

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF Medical Center, Mission Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects with above-background IS-002 fluorescent signal observed on the prostate surface that is confirmed as a positive surgical margin through pathological confirmation of malignant tissue via hematoxylin and eosin stain.	An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology	30 days
The number of lymph nodes with IS-002 fluorescent signal that contain metastatic disease as confirmed through pathological confirmation of malignant tissue via hematoxylin and eosin stain.	An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology	30 days

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: ISI-142325-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No