6 results
In Part 1 of the study, a fixed dose of ABBV-3067 (potentiator) will be co-administered with ABBV-2222 (corrector) in a dose range-finding manner to enable a dose selection for ABBV-2222 for Part 2 and future combination studies. In addition, ABBV-…
Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…
The main objective of the present study is to investigate the association between in vivo regional synaptic loss ([11C]UCB-J PET), in vivo regional tau pathology ([18F]flortaucipir PET) and in vivo regional Aβ pathology ([18F]florbetapir PET).…
Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To determine main change in ISM-SAF TSS from baseline to C7D1, compared to placebo. Part 3 • To assess the long-term…
Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40.
Primary: • The primary objective is to determine adjudicated ORR (CR/CR with partial recovery of peripheral blood counts [CRh] + PR + CI) based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib and…