Early Phase Clinical Trials for the Development of Novel Immunotherapeutic Anti-cancer Agents

  • 1,210

    Total Views and Downloads

About this Research Topic

Submission deadlines

  1. Manuscript Summary Submission Deadline 14 January 2025 | Manuscript Submission Deadline 4 May 2025

  2. This Research Topic is still accepting articles.

Background

In the dynamic landscape of oncology, drug development presents towering challenges. Historically marked by high attrition rates and decidedly low approval rates for novel therapies, this sphere demands revolutionary approaches to enhance treatment paradigms. The introduction of targeted agents and advanced immunotherapeutic strategies has significantly altered the design and goals of early-phase clinical trials. These studies have transitioned from primarily assessing safety to incorporating complex efficacy endpoints. Crucially, there is an urgent need for specialized prognostic scoring systems that address patient outcomes specifically in trials deploying new immunotherapeutic agents. These scoring systems are crucial for determining the suitability of patients for trial recruitment. Furthermore, emerging immunotherapeutic modalities such as bispecific antibodies, T-cell engagers, cancer vaccines, and CAR T-cell therapies, often in combination with immune-checkpoint inhibitors, introduce complex adverse events. These scenarios require uniquely tailored management strategies and flexible trial designs to account for variables like late-onset toxicities and interim dose adjustments based on evolving toxicity data.

This Research Topic aims to deepen our understanding of recent innovations in early-phase clinical trials for novel immunotherapeutic agents in oncology. Our objectives are to refine trial designs for greater efficacy in the drug development process, optimize patient selection strategies at the onset of studies to enhance therapeutic potential, implement pharmacodynamics markers for new anti-cancer immunotherapies, and develop expertise in managing the adverse events associated with next-generation immunotherapeutic agents.

To further this knowledge, we invite contributions that explore a wide range of themes pertinent to this field, including but not limited to:
- Case Reports that detail unique toxicities and their management techniques when employing new immunotherapeutic modalities.
- Review Articles that provide up-to-date, precise analyses of progresses in early-phase immunotherapeutic drug development, highlighting gaps, controversies, and offering new perspectives and critiques.
- Original Research Articles that describe clinical trials in the initial stages of developing novel immunotherapeutic anti-cancer agents, particularly those examining individual variances in toxicity or response rates, such as predictive biomarkers.

Topic Editor Dr. Maria Vieito is on the Advisory Board for BMS and Speaker's Bureau for Novocure. 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 on the Advisory Board for Servier, Incyte, GSK and BMS and is responsible for Data Safety Monitoring for Sanofy. The other Topic Editors declare no competing interests with regard to the Research Topic subject.

Article types and fees

This Research Topic accepts the following article types, unless otherwise specified in the Research Topic description:

  • Brief Research Report
  • Case Report
  • Classification
  • Clinical Trial
  • Editorial
  • General Commentary
  • Hypothesis and Theory
  • Methods
  • Mini Review

Articles that are accepted for publication by our external editors following rigorous peer review incur a publishing fee charged to Authors, institutions, or funders.

Keywords: Novel immunotherapeutic agents, Bispecific antibodies, ADCs, Bispecific ADCs, T-cell engager, Vaccination, CAR T-cell therapy, Immune-related adverse events, Early phase clinical trials, Trial design

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

Frequently asked questions

  • Frontiers' Research Topics are collaborative hubs built around an emerging theme.Defined, managed, and led by renowned researchers, they bring communities together around a shared area of interest to stimulate collaboration and innovation.

    Unlike section journals, which serve established specialty communities, Research Topics are pioneer hubs, responding to the evolving scientific landscape and catering to new communities.

  • The goal of Frontiers' publishing program is to empower research communities to actively steer the course of scientific publishing. Our program was implemented as a three-part unit with fixed field journals, flexible specialty sections, and dynamically emerging Research Topics, connecting communities of different sizes and maturity.

    Research Topics originate from the scientific community. Many of our Research Topics are suggested by existing editorial board members who have identified critical challenges or areas of interest in their field.

  • As an editor, Research Topics will help you build your journal, as well as your community, around emerging, cutting-edge research. As research trailblazers, Research Topics attract high-quality submissions from leading experts all over the world.

    A thriving Research Topic can potentially evolve into a new specialty section if there is sustained interest and a growing community around it.

  • Each Research Topic must be approved by the specialty chief editor, and it falls under the editorial oversight of our editorial boards, supported by our in-house research integrity team. The same standards and rigorous peer review processes apply to articles published as part of a Research Topic as for any other article we publish.

    In 2023, 80% of the Research Topics we published were edited or co-edited by our editorial board members, who are already familiar with their journal's scope, ethos, and publishing model. All other topics are guest edited by leaders in their field, each vetted and formally approved by the specialty chief editor.

  • Publishing your article within a Research Topic with other related articles increases its discoverability and visibility, which can lead to more views, downloads, and citations. Research Topics grow dynamically as more published articles are added, causing frequent revisiting, and further visibility.

    As Research Topics are multidisciplinary, they are cross-listed in several fields and section journals – increasing your reach even more and giving you the chance to expand your network and collaborate with researchers in different fields, all focusing on expanding knowledge around the same important topic.

    Our larger Research Topics are also converted into ebooks and receive social media promotion from our digital marketing team.

  • Frontiers offers multiple article types, but it will depend on the field and section journals in which the Research Topic will be featured. The available article types for a Research Topic will appear in the drop-down menu during the submission process.

    Check available article types here 

  • Yes, we would love to hear your ideas for a topic. Most of our Research Topics are community-led and suggested by researchers in the field. Our in-house editorial team will contact you to talk about your idea and whether you’d like to edit the topic. If you’re an early-stage researcher, we will offer you the opportunity to coordinate your topic, with the support of a senior researcher as the topic editor. 

    Suggest your topic here 

  • A team of guest editors (called topic editors) lead their Research Topic. This editorial team oversees the entire process, from the initial topic proposal to calls for participation, the peer review, and final publications.

    The team may also include topic coordinators, who help the topic editors send calls for participation, liaise with topic editors on abstracts, and support contributing authors. In some cases, they can also be assigned as reviewers.

  • As a topic editor (TE), you will take the lead on all editorial decisions for the Research Topic, starting with defining its scope. This allows you to curate research around a topic that interests you, bring together different perspectives from leading researchers across different fields and shape the future of your field. 

    You will choose your team of co-editors, curate a list of potential authors, send calls for participation and oversee the peer review process, accepting or recommending rejection for each manuscript submitted.

  • As a topic editor, you're supported at every stage by our in-house team. You will be assigned a single point of contact to help you on both editorial and technical matters. Your topic is managed through our user-friendly online platform, and the peer review process is supported by our industry-first AI review assistant (AIRA).

  • If you’re an early-stage researcher, we will offer you the opportunity to coordinate your topic, with the support of a senior researcher as the topic editor. This provides you with valuable editorial experience, improving your ability to critically evaluate research articles and enhancing your understanding of the quality standards and requirements for scientific publishing, as well as the opportunity to discover new research in your field, and expand your professional network.

  • Yes, certificates can be issued on request. We are happy to provide a certificate for your contribution to editing a successful Research Topic.

  • Research Topics thrive on collaboration and their multi-disciplinary approach around emerging, cutting-edge themes, attract leading researchers from all over the world.

  • As a topic editor, you can set the timeline for your Research Topic, and we will work with you at your pace. Typically, Research Topics are online and open for submissions within a few weeks and remain open for participation for 6 – 12 months. Individual articles within a Research Topic are published as soon as they are ready.

    Find out more about our Research Topics

  • Our fee support program ensures that all articles that pass peer review, including those published in Research Topics, can benefit from open access – regardless of the author's field or funding situation.

    Authors and institutions with insufficient funding can apply for a discount on their publishing fees. A fee support application form is available on our website.

  • In line with our mission to promote healthy lives on a healthy planet, we do not provide printed materials. All our articles and ebooks are available under a CC-BY license, so you can share and print copies.

Participating Journals

Manuscripts can be submitted to this Research Topic via the main journal or any other participating journal.

Impact

  • 1,210Topic views
View impact