This decision follows review of the safety and pharmacokinetic data from patients treated at 550 mg once daily (Cohort 5).
'We are very pleased with the progress in the ABOYA-119 clinical trial and with the SRC's recent endorsement to commence dosing of patients with ATRN-119 at 800 mg once daily representing progress in ATRN-119 development,' said
ABOYA-119 is a Phase 1/2a multi-center, open-label, dose-escalation and expansion clinical trial designed to test ATRN-119 monotherapy in patients with advanced solid tumors harboring defined mutations in DDR pathways. Part 1 (Phase 1) of the study is assessing tolerability, pharmacokinetics, recommended Phase 2 dose (RP2D) and analysis of patient biomarkers. At completion of Part 1, the company anticipates identification of a recommended Phase 2 dose that will be used in a Phase 2a cohort expansion (Part 2) to test the tolerability and potential efficacy of ATRN-119 monotherapy For more information, refer to please refer to clinicaltrials.gov NCT04905914.
A total of 17 patients have been enrolled in the first five cohorts of the dose escalation stage (50 mg once daily, 100 mg once daily, 200 mg once daily, 350 mg once daily, and 550 mg once daily). Based on the safety profile, in
Preliminary signs of clinical benefit have been observed with two patients (data cutoff of
Initial efficacy data from Part 1 of the study may potentially be announced in 2H 2024. The Phase 1 dose escalation is expected to be completed in 4Q 2024, and RP2D is expected to be determined in 1Q 2025. Enrollment in the Phase 2a cohort is expected to begin in 1Q 2025 with additional safety and efficacy data expected in 3Q 2025.
ATRN-119 is a differentiated, potent and highly selective first-in-class macrocyclic inhibitor of ATR, a clinically validated target. It designed to be given to patients with mutations in DDR-related genes. Cancers with mutation in DDR-related genes represent a high unmet medical need and these patients have poor prognosis and, currently, have no approved effective therapies.
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