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Phase 1 including first-in-human clinical trials to test biomarker-guided medicines or multi-modal treatment interventions for patients with rare or very rare cancers or cancer subtypes

Horizon Europe · HORIZON-MISS-2027-02-CANCER-03

Funds phase 1 and first-in-human clinical trials of biomarker-guided medicines or multi-modal treatments for patients with rare or very rare cancers.

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O čem je ta razpis?

The call funds research and innovation projects that run phase 1 clinical trials, including first-in-human trials, of biomarker-guided medicines or multi-modal treatments for rare and very rare cancers. Consortia should involve multidisciplinary stakeholders and health authorities.

Kaj ta razpis financira?

Background

Patients with rare and very rare cancers often have advanced disease at diagnosis, few treatment options, lower five-year survival and limited access to suitable phase 1 trials.

Scope

Proposals should address all of the following:

  • Where still needed, complete preclinical validation of promising biomarker-guided drugs for rare or very rare cancer indications using in vivo, ex vivo and/or in silico models, considering drug repurposing.
  • Validate early safety and efficacy of innovative medicines, alone or within multi-modal treatment, in phase 1 trials, including first-in-human and multi-centre trials, considering new trial designs.
  • Define primary and secondary endpoints covering safety, efficacy and patient-reported outcomes together with patients and caregivers.
  • Disaggregate data by tumour biology, sex, gender, age and other relevant variables, register datasets in the European Health Data Space catalogue and make tools available through the future UNCAN.eu platform.

Expected outcomes

  • Patients with rare cancers gain access to promising treatments through follow-up trials or compassionate use programmes.
  • Researchers, physicians, start-ups, SMEs, charities and other actors gain access to technologies and medicines for further validation or commercialisation.
  • Health authorities and policymakers obtain early safety and efficacy evidence to support further testing of affordable treatments.

Ključni podatki o razpisu na kratko

Proračun teme
24.000.000 €
Najnižji znesek na projekt
7.000.000 €
Najvišji znesek na projekt
9.000.000 €
Oznaka razpisa
HORIZON-MISS-2027-02-CANCER-03
Program
Horizon Europe
Funder
European Union, Horizon Europe (Cancer Mission)
Expected number of projects
3

Kdo se lahko prijavi na ta razpis?

  • Applicants should include proof of advice from regulators on the design of the clinical trial(s).
  • Consortia should include an appropriate mix of stakeholders from various disciplines, together with regional and national health authorities.
  • Successful proposals will be asked to join the Cancer Mission "Diagnosis and treatment" cluster.

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Kaj se pričakuje od predlogov?

  • Details of the clinical study(ies) should be provided in the dedicated annex template.

Kdaj je rok za oddajo?

16. septembra 2027 (314 dni)

21 September 2027 (single-stage)

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