Aprea expands cancer trial sites and plans Q4 2026 data update

Aprea Therapeutics (Nasdaq: APRE) said it plans to present clinical data from its ongoing Phase 1 ACESOT-1051 trial at a medical meeting in the fourth quarter of 2026, according to a company statement.

The trial is evaluating APR-1051, an oral WEE1 kinase inhibitor, in patients with advanced solid tumors. The number of active clinical sites has expanded from three to ten, and the company expects enrollment to reach 6 to 10 patients per month by the fourth quarter of 2026. Dose escalation is currently enrolling at the 300 mg cohort, within a protocol range of 10 mg to 500 mg.

Aprea also plans to add combination therapy arms to the study. In HPV-positive head and neck squamous cell carcinoma, APR-1051 will be evaluated alongside immune checkpoint therapy. In colorectal cancer, the drug will be combined with standard-of-care chemotherapy. The company said it intends to use dose levels that have already cleared safety review and shown single-agent activity in those combination arms.

As previously announced, the company is expanding enrollment to include at least 50 patients with uterine serous carcinoma or cyclin E-overexpressing, platinum-resistant ovarian cancer. Completion of dose escalation and backfill expansion is anticipated in the second quarter of 2027.

"Expanding enrollment and adding combination regimens in HPV positive head and neck cancer and colorectal cancer will broaden the clinical dataset as we advance development of ACESOT-1051," said Gene Kennedy, M.D., Chief Medical Advisor of Aprea.

The ACESOT-1051 trial is a multi-center, open-label Phase 1 study. Part 1 covers dose escalation and backfill expansion of up to 100 patients, while Part 2 is a dose selection optimization stage of up to 80 patients to determine the recommended Phase 2 dose. Primary objectives include safety, dose-limiting toxicity, and maximum tolerated dose.

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