Clinical trial · Interventional
Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer
An Open-label Study to Investigate the Tolerability, Pharmacokinetics and Anti-tumour Effect Following Photodynamic Therapy (PDT) With Single-ascending Doses of LUZ11 in Patients With Advanced Head and Neck Cancer
NCT02070432CI-TRIAL-00021227unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LUZ11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LUZ11 PDT
- description
- Study consists of two phases, in each participant: 1. Dose-finding phase with sequential periods in which single-ascending doses of LUZ11 will be titrated up to a dose that shows to be effective following photoirradiation of small spots of tumor surface. 2. Final PDT session with the previously identified individual effective dose.
- interventionNames
- Drug: LUZ11
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session
Secondary outcomes (1)
- measure
- Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Men or non-pregnant, non-breast feeding women * Karnofsky performance status of 60% or greater * Histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck * Clearly visible tumor on the oral cavity or cutaneous surface Exclusion Criteria: * Known hypersensitivity to any of the formulation ingredients * Known hypersensitivity to porphyrins * Porphyria or other diseases exacerbated by light * Tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site * Planned skin phototherapy session(s) within the study timeframe * Planned surgical procedure within the study timeframe * Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe * Existing therapy with a photosensitizing agent * Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to screening * Myocardial infarction within 6 months prior to screening * Contraindication to MRI with gadolinium * Unacceptable laboratory abnormalities * Clinically relevant 12-lead ECG abnormalities
References
Publications (0)
Data not yet available
No reference posted for this study.