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"Phase 1 Oncology Clinical Trial Designs"

Adaptive Strategies That Accelerate Milestones and De-Risk Regulatory Approval

Phase 1 oncology trials are undergoing a major shift. Traditional 3+3 designs no longer meet regulatory expectations for dose optimization or the complexity of next-generation therapies. Sponsors now need richer early dose-finding data, broader dose exploration, and stronger justification for recommended Phase 2 doses.

What This eBook Covers

• The move beyond 3+3 designs and how Project Optimus is reshaping dose-finding
• Modern model-assisted designs (BOIN, mTPI-2, Bi3+3) and when to use them
• Practical frameworks to select the right Phase 1 design based on modality, safety profile, regulatory needs, and operational readiness

What You’ll Gain

• Avoid weak dose-finding strategies that slow development
• Improve alignment with Project Optimus and global regulatory requirements
• Accelerate timelines with smarter design and build a stronger evidence base for later-phase decisions

Download your copy to design smarter, faster, and more robust Phase 1 trials.

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