SOUTH SAN FRANCISCO, Calif.– Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced that the first patient has been dosed in KZR-261-101, a Phase 1 clinical trial evaluating KZR-261, a novel, broad-spectrum, anti-tumor agent that acts through direct interaction and inhibition of the Sec61 translocon.
“Dosing the first patient with KZR-261, the first clinical candidate from our novel protein secretion platform, is an exciting milestone for Kezar as we continue to advance our oncology program and mature into a multi-asset therapeutics company,” said John Fowler, Co-Founder and Chief Executive Officer of Kezar Life Sciences. “We believe KZR-261 has a differentiated therapeutic profile which could translate into broad potential across the oncology landscape.”
KZR-261-101 is a first-in-human, open-label, multicenter, Phase 1 study of KZR-261 in patients with solid tumor malignancies. The study is being conducted in two parts, dose escalation and dose expansion, and is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, as well as to explore the preliminary anti-tumor activity of KZR-261 in subjects with locally advanced or metastatic disease for whom no therapeutics are currently available. Following safety review of all dose escalation cohorts and determination of the maximum tolerated dose or maximum administered dose, KZR-261 will be evaluated for safety and preliminary efficacy in four tumor-specific cohorts and one all-tumor cohort to determine doses recommended for Phase 2 studies.
