QSPモデリングにより、多発性骨髄腫治療におけるFIH用量選択を最適化

When preparing for first-in-human (FIH) clinical trials of ISB 2001 (NCT05862012), IGI faced a significant challenge. Translating preclinical data from animals to humans often leads to an overly conservative Minimum Anticipated Biological Effect Level (MABEL) approach for dose selection. While safe, this can result in suboptimal dosing in the trial’s initial phases, unnecessarily prolonging the timeline and escalating costs. IGI needed a proven framework to determine the most appropriate therapeutic dose for their tri-specific T-cell engager.

Certara’s Quantitative Systems Pharmacology (QSP) Center of Excellence collaborated with IGI to address the challenge. The team built a specialized QSP model for ISB 2001, leveraging their extensive biosimulation and oncology dose optimization expertise.

Key highlights of their solution include:

Developing Precision Models: Certara’s model used a Minimal Pharmacologically Active Dose (MPAD) approach. Compared to the traditional MABEL approach, this model allowed for a 50-100 times higher dose.

Regulatory Acceptance: This new approach received approvals from regulatory bodies, such as the US FDA and Australia’s HREC, supporting FIH dose determination for other TCEs as well.

The implementation of this QSP model ensured the following benefits for IGI’s clinical trial process:

Optimized Dose Selection: A higher starting dose reduced the number of patients exposed to subtherapeutic levels, enhancing efficacy evaluation in early trial phases.

Streamlined Timelines: By accelerating dose optimization, IGI minimized the overall duration and cost of the trial.

These advancements solidified IGI’s position as a trailblazer in tri-specific TCE therapy, getting life-saving treatments to patients faster.

With 600+ combined years of QSP experience, 300+ completed QSP projects, and a team of 65+ expert scientists serving over 250 clients worldwide, our expertise is unparalleled. Whether you’re determining safe dosing, assessing efficacy, addressing toxicity concerns, or evaluating competitive benchmarks, our team is here to help you make informed, data-driven decisions.

Leverage the world’s largest QSP team to tackle your most challenging questions and accelerate your drug development with confidence. At Certara, we’re bridging the gap between promising therapeutic innovations and meaningful patient outcomes. Partner with our QSP Center of Excellence to advance your drug development program confidently.