Strategies for clinical dose optimization of T cell-engaging therapies in oncology

Innovative approaches in the design of T cell-engaging (TCE) molecules are ushering in a new wave of promising immunotherapies for the treatment of cancer. Their mechanism of action, which generates an in trans interaction to create a synthetic immune synapse, leads to complex and interconnected rel...

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Main Authors: Kathryn Ball, Simon J Dovedi, Pavan Vajjah, Alex Phipps
Format: Article
Language:English
Published: Taylor & Francis Group 2023-12-01
Series:mAbs
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Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2023.2181016
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author Kathryn Ball
Simon J Dovedi
Pavan Vajjah
Alex Phipps
author_facet Kathryn Ball
Simon J Dovedi
Pavan Vajjah
Alex Phipps
author_sort Kathryn Ball
collection DOAJ
description Innovative approaches in the design of T cell-engaging (TCE) molecules are ushering in a new wave of promising immunotherapies for the treatment of cancer. Their mechanism of action, which generates an in trans interaction to create a synthetic immune synapse, leads to complex and interconnected relationships between the exposure, efficacy, and toxicity of these drugs. Challenges thus arise when designing optimal clinical dose regimens for TCEs with narrow therapeutic windows, with a variety of dosing strategies being evaluated to mitigate key side effects such as cytokine release syndrome, neurotoxicity, and on-target off-tumor toxicities. This review evaluates the current approaches to dose optimization throughout the preclinical and clinical development of TCEs, along with perspectives for improvement of these strategies. Quantitative approaches used to aid the understanding of dose-exposure-response relationships are highlighted, along with opportunities to guide the rational design of next-generation TCE molecules, and optimize their dose regimens in patients.
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institution Kabale University
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1942-0870
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spelling doaj-art-3e72b1cc99f146d7aaec4efa9cd6c54c2025-08-20T03:55:53ZengTaylor & Francis GroupmAbs1942-08621942-08702023-12-0115110.1080/19420862.2023.2181016Strategies for clinical dose optimization of T cell-engaging therapies in oncologyKathryn Ball0Simon J Dovedi1Pavan Vajjah2Alex Phipps3Clinical Pharmacology and Quantitative Pharmacology, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UKEarly Oncology R&D, AstraZeneca, Cambridge, UKClinical Pharmacology and Quantitative Pharmacology, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UKClinical Pharmacology and Quantitative Pharmacology, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UKInnovative approaches in the design of T cell-engaging (TCE) molecules are ushering in a new wave of promising immunotherapies for the treatment of cancer. Their mechanism of action, which generates an in trans interaction to create a synthetic immune synapse, leads to complex and interconnected relationships between the exposure, efficacy, and toxicity of these drugs. Challenges thus arise when designing optimal clinical dose regimens for TCEs with narrow therapeutic windows, with a variety of dosing strategies being evaluated to mitigate key side effects such as cytokine release syndrome, neurotoxicity, and on-target off-tumor toxicities. This review evaluates the current approaches to dose optimization throughout the preclinical and clinical development of TCEs, along with perspectives for improvement of these strategies. Quantitative approaches used to aid the understanding of dose-exposure-response relationships are highlighted, along with opportunities to guide the rational design of next-generation TCE molecules, and optimize their dose regimens in patients.https://www.tandfonline.com/doi/10.1080/19420862.2023.2181016T-cell engagerimmune oncologybispecific antibodydose optimizationquantitative clinical pharmacologytranslational PK/PD modeling
spellingShingle Kathryn Ball
Simon J Dovedi
Pavan Vajjah
Alex Phipps
Strategies for clinical dose optimization of T cell-engaging therapies in oncology
mAbs
T-cell engager
immune oncology
bispecific antibody
dose optimization
quantitative clinical pharmacology
translational PK/PD modeling
title Strategies for clinical dose optimization of T cell-engaging therapies in oncology
title_full Strategies for clinical dose optimization of T cell-engaging therapies in oncology
title_fullStr Strategies for clinical dose optimization of T cell-engaging therapies in oncology
title_full_unstemmed Strategies for clinical dose optimization of T cell-engaging therapies in oncology
title_short Strategies for clinical dose optimization of T cell-engaging therapies in oncology
title_sort strategies for clinical dose optimization of t cell engaging therapies in oncology
topic T-cell engager
immune oncology
bispecific antibody
dose optimization
quantitative clinical pharmacology
translational PK/PD modeling
url https://www.tandfonline.com/doi/10.1080/19420862.2023.2181016
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