Aprea Therapeutics (APRE) provided an update on the ongoing Phase 1 ACESOT-1051 study. The latest results show that, at the 100 mg APR-1051 dose level, 3 out of 4 patients achieved stable disease, as measured using RECIST v1.1 criteria. ACESOT-1051 Clinical Update; The primary objective of the trial is to characterize the safety profile, dose-limiting toxicity, maximum tolerated dose or maximum administered dose, and recommended Phase 2 dose of APR-1051. Secondary objectives are to to characterize the pharmacokinetics of APR-1051 and the major metabolites and active metabolites of APR-1051, and to assess preliminary efficacy of APR-1051; Results from Dose Level 6, show 3 out of 4 patients achieved stable disease, per RECIST v1.1 in heavily pretreated gastrointestinal and gynecologic malignancies; Disease stabilization was observed in patients with FBXW7, CCNE1, and KRASG12V + TP53 alterations ; Favorable tolerability: No dose limiting toxicities (DLTs) or unexpected safety issues reported to date; Following successful clearance of the 100 mg cohort, dose escalation has progressed to Dose Level 7
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