5 results
Induction PeriodPrimary:Demonstrate the efficacy of RPC1063 versus placebo on induction of clinical remission.Secondary:* Demonstrate the efficacy of RPC1063 versus placebo on induction of clinical response* Demonstrate the efficacy of RPC1063…
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
Primary Objective:- Number of participants with dose limiting toxicity - Number of participants with treatment-related adverse events - Number of participants with treatment-emergent adverse events- Number of participants with changes in vital signs…
Primary (Parts 1 and 2)• To evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab Primary (Part 3)Evaluate safety of reduced mandatory monitoring…
Monotherapy (Parts A, B*, D, E, F and G)Primary Objectives - Evaluate the safety and tolerability of Tarlatamab - Part A only: Determine the MTD or RP2D of Tarlatamab Secondary Objectives• Evaluate preliminary anti-tumor activity of Tarlatamab •…