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

¿De qué trata esta convocatoria?

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.

¿Qué financia esta convocatoria?

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.

¿Qué se espera de las propuestas?

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

¿Cuándo termina el plazo?

16 de septiembre de 2027 (314 días)

21 September 2027 (single-stage)