The Starting Point of Breakthrough Therapies: A Deep Dive into Early-Phase Oncology

Key insights:

• Rapidly expanding global trial landscape.
• Breakthrough modalities and precision targets.
• Regulatory shifts under Project Optimus.
• CRO-driven operational success and regional advantages.

Download our latest white paper to explore the global early-phase oncology landscape, emerging modalities, and CRO enablers driving next-generation cancer therapies.

Early-phase oncology trials mark the most critical and fast-evolving stage of cancer research, where innovative scientific advances transition into clinical reality. These studies establish the foundations of safety, dosing, and early efficacy, ultimately shaping the trajectory of all subsequent development.

Current oncology pipelines are growing rapidly, fueled by transformative modalities including cell and gene therapies, ADCs, bispecific antibodies, mRNA cancer vaccines, and radiopharmaceuticals. Precision oncology is advancing through novel targets like KRAS and WRN helicase that expand the scope of targeted therapies. In parallel, regulatory expectations are shifting, with Project Optimus reshaping dose-finding by moving the focus from maximum tolerated dose to biologically optimal dosing. This shift combined with the rapid adoption of adaptive, Bayesian, and platform trial designs signals a move away from traditional 3+3 escalation models toward more efficient, patient-centered, and data-rich approaches.

Despite rapid progress, challenges remain, with only a small fraction of oncology candidates entering Phase I ultimately reaching approval. Biomarker inconsistencies, patient selection hurdles, and regulatory variability drive attrition, reinforcing the need for experienced CRO partnerships.

Authored by Novotech, a leading global biotech CRO, this whitepaper provides an in-depth view of the early-phase oncology landscape, evolving trial designs, regulatory shifts, and the breakthrough modalities shaping next-generation cancer therapies.