Clinical trial • Phase I • Oncology
OncoFAP-23 radiolabelled with lutetium-177 for FAP-positive metastatic solid tumors
Phase I trial of OncoFAP-23 radiolabelled with lutetium-177 for FAP-positive metastatic solid tumors. 56 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- FAP-positive metastatic solid tumors
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 25-05-2024
- First CTIS Authorization Date
- 18-09-2024
Trial design
Phase I trial across 4 sites in Italy.
- Target Sample Size
- 56
Eligibility
Recruits 56 No vulnerable population selected; no assent/consent details provided..
- Vulnerable Population
- No vulnerable population selected; no assent/consent details provided.
Recruitment
- Planned Sample Size
- 56
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 56
Italy
- Earliest CTIS Part Ii Submission Date
- 05-08-2024
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 554
- Number Of Sites
- 4
- Number Of Participants
- 56
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- Department of Medicine and Surgery
- Principal Investigator Name
- Paola Anna Erba
- Principal Investigator Email
- paolaanna.erba@unimib.it
- Contact Person Name
- Paola Anna Erba
- Contact Person Email
- paolaanna.erba@unimib.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- Giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- Giuseppe.curigliano@ieo.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Diagnostic Imaging and Radiotherapy/Nuclear Medicine
- Principal Investigator Name
- Margarita Kirienko
- Principal Investigator Email
- margarita.kirienko@istitutotumori.mi.it
- Contact Person Name
- Margarita Kirienko
- Contact Person Email
- margarita.kirienko@istitutotumori.mi.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Medicina Nucleare
- Principal Investigator Name
- Secondo Lastoria
- Principal Investigator Email
- s.lastoria@istitutotumori.na.it
- Contact Person Name
- Secondo Lastoria
- Contact Person Email
- s.lastoria@istitutotumori.na.it
Sponsor
Primary sponsor
- Full Name
- Philogen S.p.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- [177Lu]Lu-OncoFAP-23
- Active Substance
- OncoFAP-23 radiolabelled with lutetium-177
- Modality
- Radiopharmaceutical
- Investigational Product Name
- L19-IL2
- Active Substance
- L19-IL2 (antibody–interleukin-2 fusion protein)
- Modality
- Peptide/protein/enzyme
- Combination Treatment
- Yes
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