On March 5, 2024 Kronos Bio, Inc. (the "Company") reported that it has amended its protocol for its clinical trial of KB-0742, an oral CDK9 inhibitor in a phase 1/2 dose escalation and expansion trial in solid tumors (Press release, Kronos Bio, MAR 5, 2024, View Source [SID1234640782]).
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To date, anti-tumor activity has been observed without grade 3/4 neutropenia in patients treated with KB-0742 at doses ranging from 10 mg to 80 mg using the current three-days-on, four-days-off dosing schedule. The Company has seen target engagement, tumor regressions and an acceptable safety profile at 60 mg dosed three-days-on, four-days-off, and have subsequently cleared 80 mg three-days-on, four-days-off.
Moving forward, the Company is pursuing a four-days-on, three-days-off dosing schedule to further increase patient time on KB-0742 at or above a therapeutic threshold. In a 3+3 design, the Company plans to dose escalate through doses of 60 mg, four-days-on, three-days-off, and 80 mg, four-days-on, three-days-off, before enrolling expansion cohorts at the latter dose and schedule (80 mg, four-days-on, three-days-off). KB-0742 clinical data from existing dose escalation and ongoing expansion cohorts are still expected in mid-2024. In the third quarter of 2024, the Company expects to provide an update from the new four-days-on, three-days-off dosing schedule and announce its plans for the dose expansion phase of the Phase 1/2 clinical trial of KB-0742. The Company currently contemplates the expansion cohort will include patients with either small cell or non-small cell lung cancer, ovarian cancer, or triple negative breast cancer and expects to announce topline data from the expansion phase in the first half of 2025.