Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.

Detailed Description
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LUZ11 is a new photosensitizer for use in photodynamic therapy (PDT) of solid tumors, such as head and neck cancer. PDT with LUZ11 involves the intravenous administration of LUZ11 followed by irradiation of the target tumor with laser light of an appropriate wavelength. The light causes the drug to react with oxygen, which forms reactive oxygen species (ROS) locally and induces tumor cells death and damages the blood vessels of the tumor thus preventing it from receiving nutrients. The primary objective of this study is to assess the tolerability of LUZ11 following single ascending doses of LUZ11. The secondary objectives of this study are to explore the LUZ11 dose that has anti-tumor effect following photoactivation and to determine LUZ11 pharmacokinetics.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: LUZ11


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LUZ11 PDT<br>Study consists of two phases, in each participant: 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. Final PDT session with the previously identified individual effective dose. | Drug: LUZ11<br>* LUZ11 i.v. administration followed by laser light irradiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability |  | Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy |  | Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, photodynamic therapy, Redaporfin, LUZ11