Description

In this QCast episode, Jullia and Tom explore the dose expansion phase of phase one oncology trials — the critical bridge between dose finding and proof of concept. They discuss how expansion cohorts confirm safety, explore early efficacy signals, and refine dose and schedule decisions, along with best practices for design, governance, and regulatory alignment that set the stage for a successful phase two. 

Key Takeaways

• Treat the dose expansion phase as a structured bridge between dose finding and phase two readiness.
• Define clear objectives, eligibility criteria, and decision rules for each cohort to maintain scientific focus.
• Align dose and schedule choices with exposure–response evidence and biological rationale.
• Build flexibility into the protocol through controlled adaptation and version management.
• Use pragmatic endpoints — safety, tolerability, and early activity — to inform, not confirm, efficacy.
• Maintain data integrity with cohort tagging, consistent assessments, and audit-ready documentation.
• Carry forward lessons on dose, population, and endpoints to streamline the next phase of development. 

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📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
• Biostatistics & Statistical Consultancy
• Statistical Programming & PK/PD Analysis
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• Regulatory & Submission Support
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• Post-Marketing Safety & Real-World Data

Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.