4 results
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…
The primary objective is to determine whether there is a difference in the capability of the patients to successfully follow the instructions of both the Levodopa Cyclops* and the INBRIJA® inhaler during an off episode, based on the instruction…
Primary objective: To estimate the difference in anti-proliferative activity of LEE011 600 mg QD and LEE011 400 mg QD in combination with letrozole 2.5 mg QD vs single agent letrozole 2.5 mg QD as measured by changes in Ki-67 levels from baseline to…
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 •…