Trial results for a Phase 1 study (NCT04576091) evaluating the combination of pembrolizumab, elimusertib (BAY 1895344), and stereotactic body radiation therapy (SBRT) for recurrent head and neck squamous cell cancer were posted on 2026-07-29. The study determined a maximum-tolerated dose (MTD) of 10 mg for elimusertib, with 6 participants experiencing dose-limiting toxicities (DLT).

Background

This trial investigated a combination therapy for recurrent head and neck squamous cell cancer. The regimen included pembrolizumab, an anti-cancer drug known as elimusertib (BAY 1895344), and stereotactic body radiation therapy (SBRT). Elimusertib (BAY 1895344) is designed to inhibit tumor cell growth by blocking enzymes essential for cell proliferation. SBRT is a precise radiation delivery method intended to target and eliminate tumor cells.

Trial design

The Phase 1 study (NCT04576091) enrolled 7 participants with recurrent head and neck squamous cell cancer. Specific conditions included Clinical Stage III/IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, Recurrent Head and Neck Squamous Cell Carcinoma, and Recurrent Hypopharyngeal Squamous Cell Carcinoma. The trial aimed to evaluate the best dose, potential benefits, and side effects of the combination therapy.

Key results

  • The maximum-tolerated dose (MTD) for elimusertib (BAY 1895344) in the combination regimen was determined to be 10 mg.
  • The incidence of dose-limiting toxicities (DLT) was observed in 6 participants.
  • The dose of elimusertib (BAY 1895344) administered was 10 mg.
  • There were 0 participants who experienced late adverse events.
  • The incidence of adverse events was reported in 2 participants for several categories, and in 1 participant for other categories.

What this means

The results from this Phase 1 trial establish the maximum-tolerated dose of elimusertib (BAY 1895344) at 10 mg when combined with pembrolizumab and SBRT for recurrent head and neck squamous cell cancer. The identification of an MTD and the characterization of dose-limiting toxicities and overall adverse events are crucial steps for advancing this combination therapy to further clinical development. These findings provide foundational safety data necessary for designing subsequent trials to assess efficacy in this patient population.

Source

This information was sourced from ClinicalTrials.gov, detailing trial results posted on 2026-07-29 for study NCT04576091. The full details are available on clinicaltrials.gov.