The MCLA-158-CL02 Study for Patients with Head and Neck Cancer

This study will enroll about 500 patients with head and neck cancer that have been previously treated with immunotherapy and chemotherapy. Head and neck cancer includes a group of solid tumor cancers which can occur within the mouth, tongue and/or throat. The study drug, petosemtamab, interacts with proteins in the body called EGFR and LGR5. This interaction may help the body fight this type of cancer. This drug will be compared with one of three standard of care treatments (cetuximab, docetaxel and methotrexate). Eligible participants will be randomly assigned to treatment with petosemtamab (50% chance) or to one of the three standard of care options chosen by the study doctor (also 50% chance).

Participation may last about 2 years, from screening up until the last visit. Participants will be followed for safety until the treatments are discontinued and followed for survival after discontinuing treatment on the study. Blood, tissue, and urine will be collected and tested. Optional consent will be requested for long-term storage of blood or tissue samples for future research and optional tumor biopsy or tissue collections.

In order to participate you must meet the following criteria:

• Have histologically previously confirmed head and neck squamous cell carcinoma (HNSCC) with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
• Are an HNSCC patient who has progressed on or after anti-PD-1 therapy and platinum-containing therapy.
• Have eligible HNSCC primary tumor locations of oropharynx, oral cavity, hypopharynx, and larynx.
• Have a baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.

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

• Have central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
• Have any systemic anticancer therapy within 4 weeks of the first dose of study treatment.
• Have had major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
• Have Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies.

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.