NCT05376202 (GLANS) is a Phase 1 clinical trial of Cetuximab-IRDye800CW in Penile Cancer, sponsored by University Medical Center Groningen.

Who is sponsoring NCT05376202?

NCT05376202 is sponsored by University Medical Center Groningen.

What drugs are being tested in NCT05376202?

Interventions in NCT05376202: Cetuximab-IRDye800CW.

What condition does NCT05376202 study?

NCT05376202 studies Penile Cancer, Margin Assessment.

Is NCT05376202 still recruiting?

NCT05376202 is currently completed. Last updated 19 April 2024.

Last reviewed 2024-04-19 · How we verify

NCT05376202: GLANS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Image Guided Penile Cancer Surgery

Completed Phase 1 Last updated 19 April 2024

What this trial tests

Phase 1 trial testing Cetuximab-IRDye800CW in Penile Cancer in 11 participants. Completed in 14 April 2024.

Timeline

7 March 2022

Primary endpoint
1 May 2023

14 April 2024

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	11
Start date	7 March 2022
Primary completion	1 May 2023
Estimated completion	14 April 2024
Sites	1 location across Netherlands

Drugs / interventions tested

Cetuximab-IRDye800CW — full drug profile →

Conditions studied

Penile Cancer — all drugs for Penile Cancer →
Margin Assessment — all drugs for Margin Assessment →

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Penile Cancer or Margin Assessment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main treatment modality for Penile Squamous Cell Carcinoma (PSCC) is surgery with curative intent. In organ sparing surgery a tumor-positive margin of up to 36% exist. Tumor-positive surgical margins are an independent risk factor for local recurrence, which has been reported to be up to 18%. Tumor-positive margins always lead to extra, penile sparing surgery, which leads to longer hospitalization, higher exposure to anesthetic interventions and a worse psychological outcome. Currently, no intraoperative imaging technique that provides real time feedback for resection margins exists in PSCC. Molecular fluorescence-guided Surgery (MFGS) using targeted near-infrared (NIR) optical contrast agents like for example Cetuximab-800CW is a promising technique to accommodate this need. Epidermal Growth Factor Receptor (EGFR) is overexpressed in PSCC and has safely and successfully been used as target for molecular imaging, particularly for assessment for tumor margins in head and neck squamous cell carcinoma (ICON study, UMCG1).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Monoclonal Antibodies for Targeted Fluorescence-Guided Surgery: A Review of Applicability across Multiple Solid Tumors.
Giuliani S, Paraboschi I, McNair A, Smith M, et al · · 2024 · cited 14× · PMID 38473402 · DOI 10.3390/cancers16051045
Systematic comparison of fluorescence imaging in the near-infrared and shortwave-infrared spectral range using clinical tumor samples containing cetuximab-IRDye800CW.
Keizers B, Nijboer TS, van der Fels CAM, van den Heuvel MC, et al · · 2025 · cited 7× · PMID 39553388 · DOI 10.1117/1.jbo.30.s1.s13708

Verify or expand the search:

Other recruiting trials for Penile Cancer

Currently open trials in the same condition.

NCT07378670 — DEfeating PEnile CAncer-2 · NA · recruiting
NCT07054307 — MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinom · Phase 1 · recruiting
NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers · Phase 1, PHASE2 · recruiting
NCT06684327 — Multi-cohort, Single-arm Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin in the Treatment of Rare Advanc · Phase 2 · recruiting
NCT06683846 — Ivonescimab in the Treatment of Multiple Advanced Tumors · Phase 2 · recruiting

Other University Medical Center Groningen trials

Trials by the same sponsor.

NCT06647602 — Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy · not yet recruiting
NCT06809946 — Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy · Phase 2 · not yet recruiting
NCT07527390 — CANagliflozin In DIALysis Patients · Phase 4 · not yet recruiting
NCT07439237 — Implant-supported Maxillary Overdentures; a 15-years Evaluation · not yet recruiting
NCT07275437 — Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fra · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05376202 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Medical Center Groningen
Last refreshed: 19 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05376202.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing