DOYLESTOWN, PA — Aprea Therapeutics (Nasdaq: APRE) is expanding enrollment in a Phase 1 study of its experimental cancer drug APR-1051 after early clinical data showed tumor responses and disease stabilization in patients with advanced solid tumors who had exhausted prior treatment options.
The company disclosed updated results from the ACESOT-1051 trial at the American Society of Clinical Oncology annual meeting, reporting two partial responses among patients with endometrial cancer and stable disease in six additional patients with colorectal, endometrial, and head and neck cancers.
The findings provide an early signal of anti-tumor activity for APR-1051, a WEE1 inhibitor being developed for cancers with specific genetic alterations, though the study remains focused primarily on evaluating safety and determining an appropriate dose for later-stage trials.
As of May 6, 28 patients had been enrolled across dose levels ranging from 10 milligrams to 300 milligrams daily.
The company reported that treatment-related adverse events occurred in 54% of patients, with nausea and fatigue the most common side effects. Nearly all adverse events were classified as Grade 1 or Grade 2.
Aprea indicated that the drug’s pharmacokinetic profile supports once-daily dosing, with exposure increasing proportionally across dose levels and a half-life of approximately 18 hours.
The company is now expanding the study to include at least 50 patients with uterine serous carcinoma and additional patients with cyclin E-overexpressing, platinum-resistant ovarian cancer.
Dose escalation remains underway in the 300-milligram cohort. Aprea expects to complete dose escalation and backfill expansion during the second quarter of 2027.
The ACESOT-1051 study is designed to identify a recommended Phase 2 dose while evaluating preliminary evidence of efficacy in patients with advanced solid tumors harboring cancer-associated gene alterations.
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