ALRN-6924 Breast Cancer Trial Design
We are currently conducting a clinical trial of ALRN-6924 in patients with p53-mutated breast cancer. The Phase 1b, open-label, single-arm, multicenter trial is designed to evaluate the safety, tolerability and chemoprotective effect of ALRN-6924 in up to 24 patients with p53-mutated breast cancer undergoing either neoadjuvant or adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide, a chemotherapy regimen also known as ‘TAC’.
The primary endpoints are duration and incidence of severe neutropenia (Grade 4) in cycle 1. Secondary endpoints include the chemoprotective effect of ALRN-6924 on chemotherapy-induced alopecia, as well as other hematologic and non-hematologic toxicities. TAC will be administered every 3 weeks for 4 to 6 cycles based on investigators’ discretion. ALRN-6924 will be administered at 1.2 mg/kg on 3 consecutive days in each treatment cycle, Days 0, 1 and 2, while chemotherapy will be administered on Day 1.
Upcoming Data Readouts
The planned readouts for the breast cancer trial include data from initial patients in 4Q 2022, an interim analysis on 12 patients in 2Q 2023, and topline results from 20 patients in 3Q 2023.