Oncology drug development has historically been challenging, exhibiting a very high attrition rate, with low approval rates for new treatments compared to other therapeutic areas. Currently, with the advent of new targeted agents and immunotherapeutic strategies, the design and objectives of early-phase clinical trials in oncology have changed dramatically from exploring safety to integrating criteria more ambitious efficiency measures. Prognostic scoring systems specifically addressing the outcomes of patients treated in early-phase clinical trials testing new immunotherapeutic agents are sorely needed, helping clinicians identify who might truly benefit from trial recruitment. Finally, new classes of immunotherapeutic strategies, such as bispecific antibodies, T-cell activators, cancer vaccines, chimeric antigen receptor (CAR) T-cell therapy, and their combinations with point inhibitors of immune control (and immunomodulatory antibodies against new controls) -points), present a new set of adverse events, requiring specific management and adaptive trial design, for example taking into account late toxicities and allowing intermediate dose decisions based on partial toxicity information.

The objective of the present research topic is to gain better knowledge and insight into the most recent advances in early phase clinical trials evaluating novel immunotherapeutic agents. More specifically, we aim to:
1. Investigate how to refine trial design to improve the efficiency of the drug development process.
2. Define patient selection during study enrollment, maximizing therapeutic intent (for example: optimize prognostic scores based on clinical, pathological and molecular variables).
3. Address the implementation of pharmacodynamic markers for new immunotherapeutic anticancer agents
4. Gain expertise in the management of treatment-related adverse events arising through the experimental use of next-generation immunotherapeutic agents such as bispecific antibodies, T-cell activators, cancer vaccines, lymphocyte therapy Chimeric antigen receptor (CAR) T and combinations thereof. with other standard immunomodulatory or anticancer agents (chemotherapy, radiotherapy, targeted therapy).

We accept submission of the following item types:
– Case reports describing exceptional toxicities and their management when testing novel immunotherapeutic agents such as bispecific antibodies, T-cell activators, cancer vaccines, chimeric antigen receptor (CAR) T-cell therapy , and their combinations with immune checkpoint inhibitors (and immunomodulatory antibodies). against the new checkpoints).
– Review articles providing concise and accurate updates on the latest advances in the field of early-stage immunotherapeutic drug development; reviews aim to identify gaps and controversies, and to provide new perspectives and critical assessment of current knowledge and methodology.
– Original research articles reporting clinical trials involving the first stages of the development of new immunotherapeutic anticancer agents (new compounds or new drug combinations); Of particular interest are studies investigating individual differences in toxicity or responses (i.e., predictive biomarkers).

Topic Editor Dr. Maria Vieito is a member of the BMS Advisory Board and the Novocure Speakers Bureau. Dr. Vieito has also received financial support from AstraZeneca, BeiGene, C4 Therapeutics, Novartis, Roche, Taiho Oncology and Thermo Fisher. Topic Editor Dr. Matteo Simonelli is an advisory board member for Servier, Incyte, GSK, and BMS and is responsible for data security oversight for Sanofy. The other subject editors declare no competing interests regarding the subject matter of the Research Topic.