Investigator-initiated multinational early-stage innovative clinical trials for paediatric cancer

The grant opportunity HORIZON-MISS-2025-02 focuses on advancing paediatric cancer research through multinational clinical trials. It is part of the Horizon Europe program, specifically under the EU's Cancer Mission, which aims to improve treatment outcomes for children and adolescents diagnosed with cancer. The primary goal is to provide innovative, effective, and less toxic cancer treatments and care solutions, addressing acute toxicity and long-term effects.

Eligible applicants include research institutes, universities, hospitals, healthcare practitioners, industry stakeholders, and patient advocacy groups across Europe and beyond. A strong emphasis is placed on forming multinational consortia to foster collaboration among diverse stakeholders, ensuring cross-sectoral and multidisciplinary cooperation.

The funding type is categorized as a lump sum grant within the Research and Innovation Actions framework, with a total budget of €25 million allocated for this call. Individual projects may receive between €6 million and €8 million. The grant supports early-stage clinical trials (phase 1 and 1/2) focusing on innovative approaches to paediatric cancer, which requires developing clinical tools, such as companion diagnostics, aimed at improving treatment evaluation.

The application process is a single-stage open call, and successful proposals are expected to contribute valuable data to the UNCAN.eu research data platform. The call encourages use of existing resources like paediatric cancer registries and artificial intelligence tools while emphasizing the need for effective integration of Social Science and Humanities disciplines to enhance societal impact.

The application deadline is set for September 16, 2025. While specific success rates are not provided, past competitive nature suggests they may range from moderate to low. The grant seeks projects that align with the objectives of the Cancer Mission, tackling gaps in knowledge and resources and emphasizing collaborative efforts toward combating childhood and adolescent cancers. This funding represents a significant opportunity for researchers and institutions dedicated to making meaningful advancements in paediatric oncology.

The EU Funding Opportunity is part of the Horizon Europe Programme, specifically under the call "Supporting the implementation of the Cancer Mission" (HORIZON-MISS-2025-02). The focus of this call is to improve treatments for cancer, with a particular emphasis on children (0-14 years of age) and adolescents (15-19 years of age) diagnosed with cancer.

The primary objective is to provide children and adolescents with access to innovative, more effective, and less toxic cancer treatments and care solutions, addressing both acute toxicity and long-term late effects. The funding also aims to generate scientific evidence that enables national healthcare providers, policymakers, and authorities to implement affordable and accessible treatment and care solutions within their healthcare systems. Furthermore, the initiative seeks to ensure the accessibility and re-usability of relevant trial data by researchers, innovators, and professionals, supporting the future UNCAN.eu research data platform.

The scope of the projects should include the design and execution of innovative investigator-initiated multinational early-stage clinical trials (phase 1 and 1/2) to accelerate the development of safe and targeted cancer treatments for children and adolescents, especially those with cancers that have poor prognoses (5-year overall survival rate of less than 50%). The trials should consider socio-economic and biological stratification, with data disaggregated by sex, gender, age, and other relevant variables.

Projects should also focus on developing innovative clinical tools, such as companion diagnostics, tailored to childhood and adolescent cancers. These tools should accurately evaluate treatment outcomes, monitor long-term effects, and identify potential risks like second cancers, ultimately improving patient care.

The projects are expected to provide scientific evidence that supports the implementation of affordable and accessible cancer treatments for children and adolescents within healthcare systems at local, regional, national, and associated country levels. All datasets produced should be described with metadata records in the EU dataset catalogue of the European Health Data Space, and all tools and models should leverage existing European research infrastructures, adhere to open science principles, and be made available through the UNCAN.eu platform.

The call emphasizes the importance of multinational, cross-sectoral, and multidisciplinary cooperation to address gaps in knowledge, expertise, tools, data, and resources in paediatric oncology. Projects should involve diverse stakeholders, including academia, data scientists, paediatric oncology centers, hospitals, healthcare practitioners, liquid biopsy companion diagnostics experts, cancer patients and survivors, caregivers, patient organizations, regulators, and industry. Collaboration and timely contact with regulatory authorities are crucial for informing trial design and feasibility. The use of artificial intelligence tools is encouraged, and existing resources like paediatric cancer registries should be utilized.

The call requires the effective contribution of Social Science and Humanities (SSH) disciplines, with the involvement of SSH experts and institutions to enhance the societal impact of the research activities.

Successful proposals are expected to build on the support of the Knowledge Centre on Cancer (KCC) to foster EU alignment and coordination. Consideration should be given to existing EU-funded initiatives, including PedCRIN/ECRIN, ITCC4, c4c, EU PEARL, and the European Reference Network for Paediatric Oncology (ERN PaedCan).

The Commission will facilitate coordination, and proposals should include a budget for networking, attendance at meetings, and potential joint activities. Projects will be asked to join the 'Diagnosis and Treatment' cluster for the Cancer Mission. Applicants must provide details of clinical studies in a dedicated annex using the template in the submission system.

The general conditions for this funding opportunity include:

1. Admissibility Conditions: Proposal page limit and layout as described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes and Part B of the Application Form.
2. Eligible Countries as described in Annex B of the Work Programme General Annexes, with specific provisions for non-EU/non-Associated Countries.
3. Other Eligible Conditions: Subject to restrictions for the protection of European communication networks, as described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion as described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds to ensure a balanced portfolio, grants will be awarded to at least one highest-ranked application targeting the 0-14 age group and one targeting the 15-19 age group, provided all thresholds are met.
5b. Evaluation and award: Submission and evaluation processes with thresholds of 4 for Excellence, Impact, and Implementation, and a cumulative threshold of 12.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement as described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: Eligible costs will be in the form of a lump sum.

The application and evaluation forms, as well as the model grant agreement (MGA), are available in the Submission System. Additional documents include the HE Main Work Programme 2025, HE Programme Guide, HE Framework Programme 2021/695, EU Financial Regulation 2024/2509, and other relevant guidelines and regulations.

The budget overview for the year 2025 includes several topics:

HORIZON-MISS-2025-02-CANCER-01 - HORIZON-CSA: 5,000,000 EUR, single-stage, indicative number of grants: 1
HORIZON-MISS-2025-02-CANCER-02 - HORIZON-RIA: 30,451,664 EUR, single-stage, contributions: 6,000,000 to 7,000,000 EUR, indicative number of grants: 5
HORIZON-MISS-2025-02-CANCER-03 - HORIZON-RIA: 31,000,000 EUR, single-stage, contributions: 7,000,000 to 10,000,000 EUR, indicative number of grants: 4
HORIZON-MISS-2025-02-CANCER-04 - HORIZON-RIA: 25,000,000 EUR, single-stage, contributions: 6,000,000 to 8,000,000 EUR, indicative number of grants: 4
HORIZON-MISS-2025-02-CANCER-05 - HORIZON-RIA: 15,000,000 EUR, single-stage, contributions: 3,000,000 to 5,000,000 EUR, indicative number of grants: 4
HORIZON-MISS-2025-02-CANCER-06 - HORIZON-CSA: 11,000,000 EUR, single-stage, indicative number of grants: 1

The opening date for submission is May 6, 2025, and the deadline is September 16, 2025, at 17:00:00 Brussels time.

This funding opportunity aims to foster research and innovation in paediatric oncology, encouraging collaboration among diverse stakeholders to develop and implement better treatments and care solutions for children and adolescents with cancer. It supports the Cancer Mission's objectives by addressing the unique challenges of paediatric cancers and promoting the use of advanced technologies and data-driven approaches.

In simple terms, this EU grant is about finding new and better ways to treat cancer in children and teenagers. Because kids' cancers are different from adult cancers, and the treatments we use now can have nasty long-term side effects, the EU wants researchers, hospitals, and companies to work together to develop new drugs, therapies, and tools specifically for young cancer patients. They also want to make sure that these new treatments are affordable and available to all children across Europe, and that all the data collected is shared openly to help future research. If you're a researcher, doctor, or organization working in this area, this is a chance to get funding to make a real difference in the lives of young cancer patients.

Eligible Applicant Types: The call is designed to foster collaboration among a diverse range of stakeholders. Eligible applicants include academia, data scientists, paediatric oncology centers, hospitals, healthcare practitioners, liquid biopsy companion diagnostics experts, cancer patients and survivors, caregivers, patients and survivors organisations, regulators, and industry. This suggests a broad eligibility encompassing research institutes, healthcare providers, patient advocacy groups, and private sector companies.

Funding Type: The funding type is primarily a grant, specifically a HORIZON Lump Sum Grant, under the HORIZON Research and Innovation Actions (RIA) framework. There are also Coordination and Support Actions (CSA).

Consortium Requirement: The opportunity strongly encourages multinational, cross-sectoral, and multidisciplinary cooperation. Therefore, a consortium of multiple applicants is expected, rather than a single applicant.

Beneficiary Scope (Geographic Eligibility): The call is open to applicants from Europe and beyond, including European regions, Member States, and Associated Countries. The mention of non-EU/non-Associated Countries suggests that some international participation is possible, subject to specific provisions outlined in the Horizon Europe Programme Guide.

Target Sector: The primary target sector is health, specifically paediatric oncology. This includes research and innovation in cancer treatments, clinical tools, companion diagnostics, and healthcare systems related to childhood and adolescent cancers. The program also touches on sectors like biotech/medtech, pharma/healthcare, artificial intelligence, and data science. Social Science and Humanities (SSH) are also mentioned as requiring effective contribution.

Mentioned Countries: While no specific countries are explicitly named, the opportunity is targeted towards European regions, Member States, and Associated Countries. It also mentions non-EU/non-Associated Countries, indicating a broader international scope.

Project Stage: The opportunity targets early-stage clinical trials (phase 1 and 1/2). Therefore, the expected project stage is development and validation, focusing on translating research into clinical applications.

Funding Amount: The funding amounts vary depending on the specific action. For HORIZON-CSA (Coordination and Support Actions), the budget is around €5,000,000 or €11,000,000, with one grant expected for each. For HORIZON-RIA (Research and Innovation Actions), the budget ranges from €15,000,000 to €31,000,000, with individual contributions ranging from €3,000,000 to €10,000,000, and the number of grants varying from 4 to 5 depending on the action.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant to support their research and innovation activities.

Application Stages: The application process involves a single stage.

Success Rates: The success rates can be estimated based on the indicative number of grants and the total budget allocated to each topic. However, without knowing the expected number of applications, it's difficult to provide a precise success rate.

Co-funding Requirement: The text does not explicitly mention a co-funding requirement.

Summary: This Horizon Europe call, supporting the implementation of the Cancer Mission, focuses on investigator-initiated multinational early-stage innovative clinical trials for paediatric cancer. The call aims to improve treatments for children and adolescents (0-19 years old) with cancer by addressing the gap in knowledge, expertise, tools, data, and resources in paediatric oncology. It encourages multinational, cross-sectoral, and multidisciplinary cooperation, bringing together diverse stakeholders such as academia, data scientists, hospitals, healthcare practitioners, industry, and patient organizations. The call seeks proposals that design and conduct innovative early-stage clinical trials, develop innovative clinical tools for assessing tumour response, and provide scientific evidence for affordable and accessible treatments. The funding is provided as a lump sum grant, and the application process involves a single stage. The call is open to applicants from Europe and beyond, and successful proposals are expected to contribute to the UNCAN.eu research data platform and align with the objectives of the Cancer Mission.