Thursday 16 October, 2025
Objectives: T cell engaging bispecific antibodies (T-BsAb) and chimeric antigen receptor T cells (CAR-T) are very promising types of immunotherapy for…
Read morePoster: Drug/Disease Modelling - Oncology
Optimizing first-in-human dose for HPN536, a T-Cell Engager Targeting Mesothelin: comparison of MABEL PK-driven approach and mechanistic translational PK/RO/PA modeling
Thursday 16 October, 2025
Objectives: Mesothelin (MSLN) is a glycophosphatidylinositol-linked tumor antigen found to be significantly upregulated in various malignancies, including ovarian, pancreatic, and…
Read moreDevelopment of a joint tumor size (TS)–overall survival (OS) modelling and simulation (M&S) framework supporting oncology development decision making
Thursday 16 October, 2025
Objectives: Early oncology development programs are often limited to base decision making on overall response rate endpoints due to immature…
Read moreDevelopment of a translational pharmacokinetic-biomarker-efficacy model in mouse to support dose recommendation in human
Thursday 16 October, 2025
Objectives: In the preclinical phase of oncology drug development, a common way to test the activity of a drug is…
Read moreMechanistic modeling of a novel oncolytic virus, V937, to describe viral kinetic and dynamic processes following intratumoral and intravenous administration
Thursday 16 October, 2025
Objectives: Oncolytic viral therapy represents a promising class of immunotherapy which relies on the ability of the oncolytic virus to…
Read moreCharacterizing exposure of apalutamide and its active metabolite, N-desmethyl-apalutamide, in healthy and castration-resistant prostate cancer subjects
Thursday 16 October, 2025
Objectives: Apalutamide is an androgen receptor inhibitor approved for treatment of high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) subjects [1,2]. The…
Read moreA joint modeling approach leveraging intravenous data to support dose selection of subcutaneous isatuximab in combination with pomalidomide-dexamethasone in relapsed/refractory multiple myeloma
Thursday 16 October, 2025
Introduction: Intravenous (IV) isatuximab (Isa) plus pomalidomide-dexamethasone (Pd) is approved for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). Subcutaneous…
Read moreExposure-safety analysis of Tovorafenib (DAY101), an investigational oral pan-RAF kinase inhibitor, in oncology patients with solid tumors
Thursday 16 October, 2025
Objectives: The MAPK pathway, regulates key cell functions, and is altered in many types of cancer. BRAF, a frequently altered gene,…
Read moreProspective Evaluation of a Model-Based approach to select Phase 1 Dosing Regimen for MEN1309/OBT076, a novel antibody drug conjugate (ADC) targeting Ly75 antigen for the treatment of CD205-positive metastatic solid tumours and Non-Hodgkin lymphoma
Thursday 16 October, 2025
Objectives: The aim of this work is to prospectively evaluate the model-based approach used to select Phase 1 study dosing…
Read moreDose Fractionation Study Design and PK/PD Model Analysis to Establish the Quantitative Pharmacology of Selective Aurora A Kinase Inhibition by Compound X and LY3295668
Thursday 16 October, 2025
Objectives: During early drug discovery, characterising the quantitative pharmacology of early tool compounds is an important component of candidate design…
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