Blue-Light Therapy + Sonidegib for Basal Cell Carcinoma

Overseen By Sonja Stutzman Clinical Trial Manager, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nathalie Zeitouni

Must not be taking: Photosensitizers, Immunosuppressants, Chemotherapy

Disqualifiers: Women of childbearing potential, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the use of a combination of blue-light therapy and the drug Sonidegib (also known as Odomzo or sonidegib phosphate) to treat basal cell carcinoma, a common type of skin cancer. The goal is to determine if this combination can effectively treat multiple cancer spots without causing scars, unlike traditional methods such as surgery. Individuals with at least three basal cell lesions who cannot or prefer not to undergo surgery might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking immunosuppressive medications or have used certain cancer treatments recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Sonidegib, a drug for advanced basal cell skin cancer, shrank tumors in over 90% of patients in a study. The FDA has approved it for treating locally advanced basal cell skin cancer, indicating general safety. Common side effects include muscle pain, tiredness, and hair loss, but these are usually manageable.

Photodynamic therapy with blue light, already used in other skin treatments, is well-tolerated. It can make the skin feel warm but does not cause scarring. This combination treatment aims to offer a less invasive option compared to surgery or freezing, which often cause scarring.

Overall, the treatment appears safe, but as this is an early phase study, further research is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the combination of Blue-Light Photodynamic Therapy (PDT) and Sonidegib for treating basal cell carcinoma because it offers a novel dual approach that targets the cancer in unique ways. While traditional treatments like surgery or topical creams directly remove or target cancer cells, Blue-Light PDT uses a photosensitizing agent activated by light to destroy cancer cells non-invasively. Sonidegib, an oral medication, inhibits the Hedgehog signaling pathway, which is crucial in the development of basal cell carcinoma. This combination could potentially enhance effectiveness by attacking the cancer from two different angles, offering hope for better outcomes with less invasive methods.

What evidence suggests that this combination treatment could be effective for basal cell carcinoma?

Research has shown that Blue-Light Photodynamic Therapy combined with Sonidegib may help treat basal cell carcinoma (BCC), a common type of skin cancer. In this trial, all participants will receive Sonidegib, a pill that blocks signals necessary for cancer cell growth, alongside Blue-Light Photodynamic Therapy. One study found that a light-activated drug called ALA, used with blue light, cleared cancer spots in 82.4% of patients, indicating significant tumor reduction. While these early results are promising, further research is needed to fully understand the treatment's effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Nathalie Zeitouni, MD

Principal Investigator

Medical Dermatology Specialists

Are You a Good Fit for This Trial?

This trial is for individuals with multiple basal cell carcinoma lesions, a common type of skin cancer. It's aimed at those who seek an alternative to freezing or surgical removal, which can leave scars.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document in English

Evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial

I am a man or a woman unable to have children, and I am 18 or older.

Exclusion Criteria

Subjects who have received any type of solid organ transplant

A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures

Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sonidegib 200 mg by mouth every day for 3 months and undergo three PDT sessions with topical application of ALA at Day 7, Day 30, and Day 90

12 weeks

3 visits (in-person) for PDT sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blue-Light Photodynamic Therapy
• Sonidegib

Trial Overview The study tests combining Blue-light photodynamic therapy (using the BLU-U device and a drug called ALA) with Sonidegib medication to treat skin cancer without scarring.

How Is the Trial Designed?

Group I: Blue-Light Photodynamic Therapy and Sonidegib Experimental Treatment 2 Interventions

All subjects will receive Sonidegib (ODOMZO) 200mg by mouth every day on an empty stomach (1 hour before or 2 hours after a meal) for 3 months, and PDT with topical application of ALA for a total of 3 sessions. PDT will be first administered at Visit 3 (Day 7), Visit 4 (Day 30), and Visit 5 (Day 90).

Who Is Running the Clinical Trial?

Nathalie Zeitouni

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

In a comparison of sonidegib and vismodegib for treating advanced basal cell carcinoma, sonidegib showed a lower overall incidence of adverse events (AEs) and a slower onset of these events, suggesting it may be a safer option for patients.

Common AEs included muscle spasms and alopecia, with sonidegib patients experiencing fewer severe side effects compared to vismodegib, although further studies are needed to confirm these findings due to the lack of direct head-to-head trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key Clinical Adverse Events in Patients with Advanced Basal Cell Carcinoma Treated with Sonidegib or Vismodegib: A Post Hoc Analysis. Gutzmer, R., Loquai, C., Robert, C., et al.[2022]

Sonidegib, a Hedgehog pathway inhibitor, effectively induced remission in two patients with locally advanced basal cell carcinoma (BCC) within 7 months, demonstrating its efficacy in challenging cases where surgery or radiotherapy is not an option.

Mild adverse effects such as cramps, alopecia, ageusia, and weight loss were reported, aligning with the known safety profile of sonidegib, indicating it is generally well-tolerated in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with sonidegib in patients with advanced basal cell carcinoma: case reports. Puig, S., Serra-Guillén, C., Pérez-Pastor, G., et al.[2022]

In the Phase II BOLT study, sonidegib (200 mg daily) demonstrated a high objective response rate (ORR) of 71.2% in patients with locally advanced basal cell carcinoma (laBCC) over 42 months, indicating its efficacy as a treatment option.

The efficacy of sonidegib was maintained in patients taking select concomitant medications, with an ORR of 73.0%, suggesting that it can be safely administered alongside other treatments, except for strong cytochrome P450 3A4/5 inhibitors/inducers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant medication use does not appear to alter long-term efficacy of sonidegib for advanced basal cell carcinoma: a post hoc analysis based on the 42-month BOLT study. Lear, JT., Robert, C., Grob, JJ., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06623201

Blue-Light Photodynamic Therapy and Sonidegib for ... Blue light PDT has shown some success in treating BCCs, but more research is needed to evaluate this treatment modality further. The objective of this study is ...

2. trial.medpath.com trial.medpath.com/clinical-trial/ad0594dcf5b8f036/blue-light-photodynamic-therapy-sonidegib-basal-cell-carcinomas

Blue-Light Photodynamic Therapy and Sonidegib for Multiple ... Blue light PDT has shown some success in treating BCCs, but more research is needed to evaluate this treatment modality further. The objective ...

3. careacross.com careacross.com/clinical-trials/trial/NCT06623201

Blue-Light Photodynamic Therapy and Sonidegib for ... This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025002625

Efficacy and empirical analysis of electrodesiccation ... High-risk BCC treated with ET combined with ALA-PDT showed a cure rate of 98.55% and a recurrence rate of 1.45% at 1 year or more (average ...

5. firstwordpharma.com firstwordpharma.com/story/5038381

ODOMZO ® (sonidegib) and LEVULAN ® KERASTICK ... Significantly Greater Clearance of Cumulative Disease Area - Eight out of 10 patients (82.4%) treated with PDT using LEVULAN KERASTICK + BLU-U ...

6. withpower.com withpower.com/trial/phase-1-carcinoma-basal-cell-11-2024-03c51

Blue-Light Therapy + Sonidegib for Basal Cell Carcinoma Research shows that Sonidegib, a drug used for advanced basal cell carcinoma, led to significant tumor shrinkage in over 90% of patients in a study, and 43% of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7211768/

Sonidegib: Safety and Efficacy in Treatment of Advanced ... Sonidegib (Odomzo ® ), an oral smoothened (SMO) antagonist, is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC)