Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IS-002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels
- interventionNames
- Drug: IS-002
Primary outcomes (1)
- measure
- Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
- timeFrame
- 14 days
- description
- Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0
Secondary outcomes (4)
- measure
- IS-002 Maximum Plasma Concentration (Cmax)
- timeFrame
- -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available