Clinical trial • Phase I • Oncology
Gallium-68 labelled R54 ([68Ga]Ga-R54) for Advanced solid tumours (CXCR4-positive) | Breast cancer | Lung cancer | Colorectal cancer | Ovarian cancer | Pancreatic cancer
Phase I trial of Gallium-68 labelled R54 ([68Ga]Ga-R54) for Advanced solid tumours (CXCR4-positive) | Breast cancer | Lung cancer | Colorectal cancer | Ov…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumours (CXCR4-positive) | Breast cancer | Lung cancer | Colorectal cancer | Ovarian cancer | Pancreatic cancer
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 05-07-2024
- First CTIS Authorization Date
- 15-10-2024
Trial design
None/Not specified-controlled Phase I trial across 1 site in Italy.
- Comparator
- None/Not specified
- Biomarker Stratified
- True; biomarker: CXCR4 expression by immunohistochemistry; strata: CXCR4-positive
- Target Sample Size
- 10
- Trial Duration For Participant
- 730
Eligibility
Recruits 10 Vulnerable population not selected (isVulnerablePopulationSelected=false)..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false).
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 10
Italy
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 580
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Nuclear Medicine Unit
- 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
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- [68Ga]Ga-R54 (CXCR4-targeted radiopharmaceutical)
- Active Substance
- Gallium-68 labelled R54 ([68Ga]Ga-R54)
- Modality
- Radiopharmaceutical
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