Athenex initiates Phase 1/2 Oraxol study

Athenex announced that it has initiated a Phase I/II clinical study to assess the safety, tolerability and activity of Oraxol in combination with an anti-PD1 antibody in patients with advanced solid malignancies, in collaboration with Mayo Clinic. Oraxol is an innovative oral formulation of paclitaxel, an effective and commonly used anti-cancer chemotherapy, combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor. Pembrolizumab is a checkpoint inhibitor approved by FDA. The study is a Phase I/II study being conducted in patients with urothelial, gastric/gastroesophageal or non-small cell lung cancer that have previously failed treatment with a checkpoint inhibitor. The primary outcome measures are tumor response rate and determination of maximum tolerated dose, while the secondary outcome measures include progression free survival, overall survival, duration of response and pharmacokinetics.
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