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Call key data
Investigator-initiated multinational early-stage innovative clinical trials for paediatric cancer
Funding Program
Horizon Europe: Missions
Call number
HORIZON-MISS-2025-02-CANCER-04
deadlines
Opening
06.05.2025
Deadline
16.09.2025 17:00
Funding rate
100%
Call budget
€ 25,000,000.00
Estimated EU contribution per project
between € 6,000,000.00 and € 8,000,000.00
Link to the call
Link to the submission
Call content
short description
This topic will contribute to the achievement of the Mission’s objective to provide better treatments for cancer. The focus is on children (0-14 years of age, e.g. age of first cancer diagnosis) and/or adolescent (15-19 years of age, e.g. age of first cancer diagnosis) cancer patients.
Call objectives
Paediatric oncology has made considerable progress, increasing patient survival rates up to 80%; yet cancer remains the leading cause of death in children and adolescents. Progress in R&I to support the development of targeted cancer treatments for children has been rather limited. Over the past 20 years, less than 10% of new anti-cancer drugs have received marketing authorization for paediatric use, resulting in limited availability of innovative therapies to treat paediatric cancers. This is even more striking when cancers with poor prognosis are considered.
Most of the treatments currently used for paediatric cancers have been developed to treat adult cancers; in addition, young cancer patients and survivors very often experience adverse late-effects due to the high toxicity of treatments. Clinical tools used to evaluate treatment outcomes (e.g. tools to assess toxicity, radiological response, quality of life etc.), are also derived from adult oncology and therefore suboptimal;
This situation mostly reflects the fact that paediatric cancers are rare, and their biology is different to adult cancers. The relatively low number of cases warrants the implementation of multinational academic-initiated clinical trials to accelerate the development of innovative, more effective and less toxic treatments.
Proposals should address all of the following:
- Design and conduct innovative investigator-initiated multinational early-stage clinical trials, (phase 1 and 1/2) to accelerate the development of safe, effective, targeted cancer treatments for children and/or adolescents with cancer. Focus should be on cancers with poor prognosis (e.g. with a 5-year overall survival less than 50% from time of diagnosis) at any stage of the disease and for any type. Trials should take into account socio-economic and biological stratification. All data should be disaggregated by sex, gender, age and other relevant variables;
- Develop innovative clinical tools (companion diagnostics) to assess tumour response, tailored to childhood and adolescent cancers, enabling an accurate evaluation of treatment outcomes, monitoring of long-term effects of treatment, and identification of potential risks such as second cancers, thereby improving overall patient care;
- Ultimately, provide scientific evidence to deliver affordable and accessible treatments for children and adolescents with cancer to be implemented by healthcare systems at the level of local communities, European regions, Member States and Associated Countries;
- All datasets produced should be described with metadata records in the EU dataset catalogue of the European Health Data Space, while all tools and models should take advantage of current European research infrastructures, should follow the principles of open science and made available through the future UNCAN.eu platform.
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Expected effects and impacts
The topic is designed to fill a gap in terms of knowledge, expertise, tools, data and resources in paediatric oncology, to be achieved through multinational, cross-sectoral and multidisciplinary cooperation.
For that purpose, projects should bring together a diverse range of stakeholders and organizations from across Europe and beyond, including 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 etc., to foster collaboration and accelerate the development of innovative cancer treatments and therapeutic approaches including companion diagnostics. Timely contact with regulatory authorities should be foreseen to inform the trial design and feasibility. Use of artificial intelligence tools is encouraged, whenever relevant. Existing resources such as paediatric cancer registries should be appropriately exploited.
This topic requires the effective contribution of Social Science and Humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise in the successful proposal, to produce meaningful and significant effects enhancing the societal impact of the related research activities.
Successful proposals are expected to build on the support of the Knowledge Centre on Cancer (KCC) to foster EU alignment and coordination. Due consideration should be given to existing EU-funded initiatives (and if relevant other initiatives), including PedCRIN/ECRIN relevant initiatives supported by the Innovative Health Initiative, such as ITCC4, c4c, EU PEARL or the European Reference Network for Paediatric Oncology, ERN PaedCan.
The Commission will facilitate coordination. Proposals should include a budget for networking, attendance at meetings, and potential joint activities and will be asked to join the 'Diagnosis and Treatment' cluster for the Cancer Mission.
Applicants should provide details of the clinical studies in the dedicated annex using the template provided in the submission system.
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Expected results
Proposals under this topic should aim to deliver results that are directed and tailored towards and contribute to all of the following expected outcomes:
- Children and adolescents with cancer have access to innovative, more effective, less toxic treatments–both in terms of acute toxicity and long-term late effects–and care solutions;
- National healthcare providers, policymakers and authorities in European regions, Member States and Associated Countries have the scientific evidence to accelerate the implementation of affordable and accessible treatment and care solutions in their healthcare systems;
- Researchers, innovators, and professionals from different disciplines and sectors ensure accessibility and re-usability of relevant trial data, to support the future UNCAN.eu research data platform, which is currently in preparation.
Eligibility Criteria
Regions / countries for funding
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Azerbaijan (Azərbaycan), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Canada, Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), New Zealand (Aotearoa), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
eligible entities
EU Body, Education and training institution, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
Mandatory partnership
Yes
Project Partnership
To be eligible for funding, applicants must be established in one of the following countries:
- the Member States of the European Union, including their outermost regions
- the Overseas Countries and Territories (OCTs) linked to the Member States
- countries associated to Horizon Europe - see list of particpating countries
Only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:
- at least one independent legal entity established in a Member State; and
- at least two other independent legal entities, each established in different Member States or Associated Countries.
Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.
A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.
other eligibility criteria
Specific cases:
- Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
- Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
- Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
- Legal entities created under EU law (EU bodies) including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
- International European research organisations are eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’ actions or when provided for in the specific call/topic conditions. Other international organisations are not eligible to receive funding, unless provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.
- Joint Research Centre (JRC)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
- Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.
- EU restrictive measures — Entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU) as well as Article 75 TFEU, are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any).
- Legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine — Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, there is currently no appropriate context allowing the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine. Therefore, even where such entities are not subject to EU restrictive measures, such legal entities are not eligible to participate in any capacity. This includes participation as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any). Exceptions may be granted on a case-by-case basis for justified reasons.
With specific regard to measures addressed to Russia, following the adoption of the Council Regulation (EU) 2024/1745 of 24 June 2024 (amending Council Regulation (EU) No 833/2014 of 31 July 2014) concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine, legal entities established outside Russia but whose proprietary rights are directly or indirectly owned for more than 50% by a legal person, entity or body established in Russia are also not eligible to participate in any capacity. - Measures for the protection of the Union budget against breaches of the principles of the rule of law in Hungary — Following the Council Implementing Decision (EU) 2022/2506, as of 16 December 2022, no legal commitments can be entered into with Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain. Affected entities may continue to apply to calls for proposals and can participate without receiving EU funding, as associated partners, if allowed by the call conditions. However, as long as the Council measures are not lifted, such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc.).In case of multi-beneficiary grant calls, applicants will be invited to remove or replace that entity in any funded role and/or to change its status into associated partner. Tasks and budget may be redistributed accordingly.
Additional information
Topics
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
Additional Information
Applications must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.
Applications must be submitted using the forms provided inside the electronic submission system (not the templates available on the topic page, which are only for information). The structure and presentation must correspond to the instructions given in the forms.
Applications must be complete and contain all parts and mandatory annexes and supporting documents.
The application form will have two parts:
- Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
- Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.
Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).
The limit for a full application (Part B) is 50 pages.
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025). It is mandatory to submit a detailed budget table using the template available in the Submission system.
To ensure a balanced portfolio covering children and adolescents, grants will be awarded not only in order of ranking but also to at least:
- one highest ranked application that targets the age group 0-14 (children); and
- one highest ranked application that targets the age group 15-19 (adolescents)
provided that these applications attain all thresholds. Applications targeting both age groups (0-14 and 15-19) will be considered to be within both age groups for the purposes of the application of the condition above.
Call documents
Horizon Europe Work Programme 2025 - MissionsHorizon Europe Work Programme 2025 - Missions(1773kB)
Contact
RTD-HORIZON-EUROPE-MISSIONS@ec.europa.eu
Website
National Contact Points for Horizon Europe
Website
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