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

NCT04574401 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ISI-142325-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• IS-002 Maximum Plasma Concentration (Cmax)

  -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)

  -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)

  -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)

  -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours

Other Outcomes (2)

• 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.

  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.

  30 days

Study Arms (1)

Dose escalation

EXPERIMENTAL

Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels

Drug: IS-002

Interventions

IS-002 DRUG

Intravenous injection of IS-002 Investigational Drug

Dose escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

UCSF Medical Center, Mission Bay

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 5, 2020
• Study Start: October 10, 2020
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)