Objectives: The FDA has recently initiated Project Optimus to reform the dose optimization and selection paradigm in oncology drug development,…
Read morePoster: Drug/Disease Modelling - Oncology
QSP modeling of OPB-171775, a PDE3A-SLFN12 molecular glue to predict clinical respose in patients with gastrointestinal stromal tumor (GIST).
Introduction/Objectives: Gastrointestinal stromal tumor (GIST), the most common mesenchymal tumor having KIT or platelet-derived growth factor receptor A activating mutations,…
Read moreA mechanistic framework for interpretation and prediction of the PKPD/anti-tumour activity relationship of irreversible Tyrosine Kinase Inhibitors (TKIs) targeting EGFR Exon20Ins mutation
Introduction/Objectives: EGFR Exon20 insertions (Exon20Ins) are the third most common EGFR activating mutation in non-small cell lung cancer after the…
Read morePersonalizing Busulfan Exposure in Hematopoietic Cell Transplantation
Personalizing Busulfan Exposure in Hematopoietic Cell Transplantation Razan Sakran (1,2), Xiaomei Chen (2), Daniel Kurnik (1,3), Elisabet I Nielsen (2)…
Read morePopulation Pharmacokinetic (PK) and mechanistic Pharmacodynamic (PD) model analysis of PHI data for FS222, a CD137/PD-L1 tetravalent, bispecific antibody which elicits robust pharmacodynamic activity in advanced solid tumor patients in a FIH study
Introduction/Objectives: Only a fraction of cancer patients respond to monotherapies targeting the PD-(L)1 pathway (1). FS222 is a bispecific tetravalent…
Read moreModel-driven scheduling of a novel anti-cancer prodrug administered subcutaneously
Objectives Paclitaxel (Ptx) is a key chemotherapeutic, but commercial formulations cause toxicity due to emulsifiers. New Ptx formulations aim to…
Read morePreclinical PK/PD/Efficacy modelling to guide early clinical dose selection for AZD9750, a novel oral Androgen Receptor Proteolysis-targeting chimera (AR-PROTAC)
Objectives: The androgen receptor (AR) plays a pivotal role in prostate cancer pathogenesis, where it is highly expressed, making it…
Read moreCell-level Pharmacodynamics-Mediated Drug Disposition Model for GI-102 (CD80/IL2v3) in Patients with Advanced or Metastatic Solid Tumors
Introduction/Objectives: GI-102 (CD80/IL2v3) is a novel immunocytokine designed to direct interleukin-2 variant (IL-2v3) to immune cells and tumor cells. The…
Read more A population modelling framework to support early clinical development of BI-1910, an agonist monoclonal antibody to tumor necrosis factor 2
Objectives Tumor necrosis factor receptor 2 (TNFR2) is a type I transmembrane protein highly expressed by myeloid cells and specific…
Read morePredicting the pharmacokinetics of T-Cell Engagers as a function of Target-Mediated Drug Disposition
Introduction/Objectives: T-Cell Engagers (TCEs) represent a rapidly expanding class of therapeutic proteins, primarily in oncology indications with nine now approved…
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