Changing Trends in Phase 1 Oncology Clinical Trials

The Ph1 oncology trial landscape is evolving in response to advances in understanding of cancer biology, novel drug discovery platforms, and therapeutic modalities. To uncover emerging trends in oncology drug development, we identified 6,951 solid tumour Ph1 trials (2009-2021) from clinicaltrials.gov to determine the numbers of trials started, therapeutic classes, combinations, tumour types, and geographical distribution. Ph1 oncology trials increased by an average of 5%/year. There was a significant relative increase in the number of immunotherapy studies and a significant relative decrease in trials containing chemotherapy. Between 2009-2010, multi-agent combination trials outnumbered single-agent trials and single-class trials outnumbered multimodal combination trials. The proportion conducted in the Asia-Pacific significantly increased. Multiregional trials decreased during the COVID-19 pandemic, reducing projected trial numbers in Asia-Pacific and Europe whilst increasing single-region trials in North America. Further study is required to track recovery post-pandemic, and the emergence of novel modalities (e.g. ADCs and cellular therapies).