Case Study: Sutro Biopharma gains confidence in pediatric AML dose selection with Certara QSP modeling

Model-Informed Confidence in Oncology Dose Selection

Sutro Biopharma, an oncology-focused company, needed model-based justification for the proposed starting dose of their antibody-drug conjugate in a pivotal pediatric acute myeloid leukemia (AML) trial. They partnered with Certara (whose team at Applied BioMath was acquired by Certara in 2023) and used Quantitative Systems Pharmacology modeling to address this challenge.

Certara developed a PK/PD model calibrated to preclinical and clinical data to predict exposure, safety, and efficacy across various doses. This modeling supported Sutro's rationale for dose selection, which was approved by the FDA, resulting in an open IND. The solution provided significant cost and time savings by reducing the need for dose escalations and accelerating clinical development timelines.

Sutro Biopharma

Anne Borgman

Chief Marketing Officer