5 results
PrimaryTo evaluate confirmed ORR of Trastuzumab deruxtecan in human epidermal growth factor receptor 2- (HER2-) mutated NSCLC subjects treated at 5.4 and 6.4 mg/kg doses.Secundary- To evaluate the clinical efficacy of Trastuzumab deruxtecan at 5.4…
Study AG348-C-017 is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study designed to demonstrate the clinical efficacy and safety of mitapivat in subjects with α- or β NTDT. The primary objective of the study is to compare the…
Study AG348-C-018 is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study designed to demonstrate the clinical efficacy and safety of mitapivat in subjects with α- or β-TDT. The primary objective of the study is to compare the…
Primary ObjectiveTo assess the effect of ALX148 plus pembrolizumab on 12-month overall survival (OS) rate and objective response rate (ORR) in patients withmetastatic or with unresectable, recurrent HNSCC that is PD-L1 positive (CPS >=1) and…
To determine the efficacy of treatment with mitapivat compared with placebo, as assessed by the increase in Hb concentrations in pediatric subjects with PK deficiency who are not regularly transfused