Photoimmunotherapy + Anti-PD1 for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Rakuten Medical, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a new treatment combining a light-sensitive drug and an immune booster for patients with hard-to-treat head and neck or skin cancers. The goal is to see if this combination is safe and effective in shrinking tumors.

Eligibility Criteria

This trial is for adults with certain advanced squamous cell cancers in the head, neck, or skin. Participants must have at least one tumor accessible to light treatment and measurable disease. They should be relatively healthy (ECOG 0-1), not have had recent systemic cancer therapy (except if over 6 months ago as part of multimodal treatment), and agree to use effective contraception methods.

Inclusion Criteria

My skin cancer is advanced, cannot be removed by surgery or treated with radiation.

At least one site of disease accessible to light illumination

Measurable disease by modified RECIST 1.1

+9 more

Exclusion Criteria

I haven't had radiation or similar treatments in the last 4 weeks, or I've recovered from their side effects.

I am currently on medication for an infection.

I have upcoming procedures that involve significant light exposure within 4 weeks after my ASP-1929 PIT treatment.

+18 more

Participant Groups

The study tests ASP-1929 photoimmunotherapy combined with anti-PD1 drugs Pembrolizumab or Cemiplimab in patients with recurrent/metastatic head & neck squamous cell carcinoma or cutaneous squamous cell carcinoma that can't be treated by surgery/radiation.

3Treatment groups

Experimental Treatment

Group I: Sub-study 3- 2L cuSCCExperimental Treatment2 Interventions

Locally advanced or metastatic cutaneous squamous cell carcinoma

Group II: Sub-study 2- 1L cuSCCExperimental Treatment2 Interventions

Locally advanced or metastatic cutaneous squamous cell carcinoma

Group III: Sub-study 1- 1L HNSCCExperimental Treatment2 Interventions

Recurrent locally advanced and/or metastatic head and neck squamous cell carcinoma