Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1

Purpose Bintrafusp alfa (BA) is a bifunctional fusion protein composed of the extracellular domain of the transforming growth factor-β (TGF-β) receptor II fused to a human immunoglobulin G1 antibody blocking programmed death ligand 1 (PD-L1). The recommended phase 2 dose (RP2D) was selected based on...

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Veröffentlicht in:	Cancer chemotherapy and pharmacology 2022-10, Vol.90 (4), p.369-379
Hauptverfasser:	Vugmeyster, Yulia, Grisic, Ana-Marija, Wilkins, Justin J., Loos, Anja H., Hallwachs, Roland, Osada, Motonobu, Venkatakrishnan, Karthik, Khandelwal, Akash
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies Bleeding Cancer Cancer Research Chemotherapy Clinical trials Dosage Evaluation Fusion protein Growth factors Hemorrhage Immunoglobulin G Immunoglobulins Ligands Medicine Medicine & Public Health Oncology Original Original Article PD-L1 protein Pharmacodynamics Pharmacokinetics Pharmacology Pharmacology/Toxicology Population Proteins Restarting Risk assessment Risk management Statistical analysis Toxicity Transforming growth factor-b Tumors
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