The ASPEN-03 Study for Patients with Head and Neck Cancer

The purpose of this study is to study the effectiveness of the study drug, ALX148, in combination with pembrolizumab for treating head and neck cancer. The study will also assess the safety and tolerability of ALX148 with pembrolizumab, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on the cancer site together with pembrolizumab.

In this study participants will either be given ALX148 in combination with pembrolizumab or will receive pembrolizumab alone. The first 6 subjects will receive ALX148 in combination with pembrolizumab and will have more study visits to look at how ALX148 levels change over time in detail. The purpose of this “safety lead-in” group of subjects is to provide more information about the safety and tolerability of the dose of ALX148 chosen for this study in combination with pembrolizumab. After this first group, participants will be randomly (by chance) assigned to a treatment and will have a 2:1 chance of receiving ALX148 in combination with pembrolizumab (compared to receiving pembrolizumab alone).

ALX148 is a new investigational drug. An “investigational” drug is one that is currently not approved by the U.S. Food and Drug Administration and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied. ALX148 is a fusion protein (a protein generated by joining parts of two different proteins), which has been shown in animal studies to help the immune system destroy cancer cells. The other drug used in this study, pembrolizumab, is approved for treatment of head and neck cancer (and for other cancer types).

More information can be found on the website clinicaltrials.gov by searching for NCT04675294.

In order to participate you must meet the following criteria:

• Are at least 18 years of age at enrollment.
• Have metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive and have not received prior systemic therapy for their advanced disease.
• Have adequate bone marrow, liver, and renal function as determined by specific lab tests.

You will be excluded from the study if any of the following criteria apply to you:

• Have disease suitable for local therapy with curative intent.
• Have progressive disease within 6 months of completion of curative therapy.
• Have had systemic anticancer therapy within 4 weeks of starting study treatment.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.