Antibody-drug conjugates (ADCs) are transforming oncology development—but they also bring significant operational complexity. Narrow therapeutic windows, payload-driven toxicities, biomarker-dependent enrollment, and evolving regulatory expectations demand a different approach than traditional oncology trials.
This practical guide helps sponsors navigate ADC development from early- to later-phase studies, covering dose strategy in the era of Project Optimus, site readiness, biomarker-driven enrollment, and patient-centric execution. The result is a clear, phase-aware roadmap for improving enrollment, generating stronger data, and protecting patients at every step.
What’s Inside
- How Project Optimus is reshaping ADC dose-finding and why adaptive, model-based designs are becoming critical for early-phase success
- Site readiness strategies—from academic centers in FIH studies to controlled expansion into community oncology settings
- Practical ways to address the biomarker bottleneck, including pre-screening, lab strategy, and screen failure management
- A proactive framework for monitoring safety, improving retention, and embedding the patient voice into protocol design
Download the Playbook
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