Squamous Cell Carcinoma of the LarynxPhase 2STELLARNCT05752149

Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial

A Phase 2 study testing CRGD-ZW800-1 in people with Squamous Cell Carcinoma of the Larynx and Squamous Cell Carcinoma of the Hypopharynx, run by Erasmus Medical Center at 2 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is an open-label, single-dose, prospective clinical trial. The study comprises 2 work packages. The main objective of work package I (WP-1) is to assess feasibility of Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose of the cRGD-ZW800-1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Hypopharynx
What is being tested?: CRGD-ZW800-1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 2 sitesNetherlands
Study dates: 31 Mar 2026to 31 Mar 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with biopsy-proven squamous cell Laryngeal and hypopharyngeal cancer, eligible for surgical resection of the tumor by TLE;
≥ 18 years of age;
Written informed consent must be obtained;
Sufficient knowledge of the Dutch language to understand the informed consent form;

Who cannot join

History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent;
Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal, squamous cell skin carcinoma, or other head- and neck squamous cell cancer;
Patients pregnant or breastfeeding;
Patients with renal insufficiency (defined as eGFR < 60);
Patients with previous kidney transplantation or a solitary functioning kidney;
Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors), that cannot be paused during the course of the study;

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Patients with ASA classification of 4 or higher;
Patients with measured QTc of 500 ms or higher at screening;
Patients with laboratory abnormalities defined as:
Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
Total bilirubin above 3 times the ULN or;
Platelet count below 100 x 109/L or;
Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males).
Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a preexisting disease or concomitant medications;

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands2 sites, 2 recruiting

Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Stijn Keereweer, MD, PhD
Not yet recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Stijn Keereweer, MD, PhD, 0107041357, s.keereweer@erasmusmc.nl
Recruiting

Other trials in Netherlands

About this study

Official title: The STELLAR Trial: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial

Read the detailed description

This is a two staged clinical trial to investigate intraoperative fluorescence imaging in patientsundergoing TLE. WP-I is a dose finding study in which 2 doses will be tested with a possibility of a third dosing group. Every dosing cohort comprises 3 patients. After WP-I, an interim analysis will be performed to decide the optimal dose.

The optimal dose will be based on the TBR and the performance in detecting the most close margin (i.e. 'the sentinel margin'). A TBR of at least 1.5 is required for the optimal dose. If a positive margin is missed with fluorescence imaging, the concerned dose will be defined as suboptimal.

WP-II is an extension cohort of the optimal dose cohort selected in WP-I. WP-II will comprise of 18 patients.

The endpoints for WP-II are:

the rate of tumor free resection margins based on the current golden standard;
Sensitivity, specificity and positive predictive value of FLI;
The intraoperative change in surgical management based on FLI;
FLI of excised cervical lymph nodes;
Influence of previous radiotherapy on the FLI performance;
Adverse events and toxicity after intravenous injection with cRGD-ZW800-1;

Conditions: Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Hypopharynx
Being tested: CRGD-ZW800-1
Keywords: Tumour specific fluorescence imaging
Medical subject headings: Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRGD-ZW800-1Drug
Intravenous administration of study drug at lesat 2h prior to surgery

Study groups in NCT05752149
Study group	Role	What they receive
0.05 mg/kg cRGD-ZW800-1	Experimental	n=3. Injection of 0.05 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery Receives: Drug: CRGD-ZW800-1
0.025 mg/kg cRGD-ZW800-1	Experimental	n=3. Injection of 0.025 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery Receives: Drug: CRGD-ZW800-1
0.01 mg/kg cRGD-ZW800-1	Experimental	n=3. Injection of 0.01 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery. Receives: Drug: CRGD-ZW800-1
Expansion Cohort	Experimental	n=18: expansion cohort will be added to the group of patients that had received the selected dose in WP-I. Receives: Drug: CRGD-ZW800-1

What is being measured

The primary outcome is the main question the study is designed to answer.

WP-I: the optimal dose of cRGD-ZW800-1 for FLI of laryngeal and hypopharyngeal cancer
Based on the tumor-to-background ratio (TBR) on breadloaves. Higher TBRs indicate a better outcome
Measured: Up to 48 hours after administration (Depending on pathology grossing)
WP-II: the rate of clear tumor resection margins
Measured: Through histopathology, up to max 4 weeks post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 202631 Mar 2028

First posted2 Mar 2023
Study start31 Mar 2026
Primary completion31 Mar 2028 (estimated)
Study completion31 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Squamous Cell Carcinoma of the LarynxStudies of the same condition, open and under way.
More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Care provider
Enrolment: 27 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05752149
Sponsor's protocol ID: NL74742.078.21
Acronym: STELLAR
Status last verified: Sep 2026
First submitted: 21 Feb 2023
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Uponr reasonable reasonable request

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
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Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma
HNSCC,Larynx, Pharynx and Oral Cavity, Squamous Cell Carcinoma
Active, not recruiting
Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy
Squamous Cell Carcinoma of Oral Cavity, Pharynx Carcinoma
RecruitingPhase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
Malignant Neoplasms of Respiratory and Intrathoracic Organs, Squamous Cell Carcinoma of the Larynx
Not yet recruiting
Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx

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