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Aprea Therapeutics Announces that Safety Review Committee (SRC) Endorses Dosing of Patients with ATRN-119 at 800 mg Once Daily in Ongoing ABOYA-119 Clinical Trial
Aprea Therapeutics announced that the Safety Review Committee (SRC) has approved dosing patients with ATRN-119 at 800 mg once daily in the ongoing ABOYA-119 clinical trial. ATRN-119, the first macrocyclic ATR inhibitor in clinic trials, has demonstrated a favorable safety profile through five dosage levels (up to 550 mg) with no dose-limiting toxicities. This advancement allows for Cohort 6 enrollment and positions Aprea to complete dose escalation and potentially release initial efficacy data by the second half of 2024. Clinical data show increasing systemic drug exposure with higher doses, and preliminary benefits observed in the trial include stable disease in two patients. The Phase 1 dose escalation is expected to conclude by the fourth quarter of 2024, with a recommended Phase 2 dosage to be identified by early 2025. Further Phase 2a cohort studies will begin in early 2025, aiming to evaluate ATRN-119's efficacy in advanced solid tumors with specific DDR pathway mutations.
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