Clinical trial • Phase I • Oncology
Pembrolizumab for Advanced solid malignancies
Phase I trial of Pembrolizumab for Advanced solid malignancies. 80 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid malignancies
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-03-2025
- First CTIS Authorization Date
- 07-07-2025
Trial design
Phase I trial across 1 site in Poland.
- Target Sample Size
- 80
Eligibility
Recruits 80 No vulnerable populations selected..
- Vulnerable Population
- No vulnerable populations selected.
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 19
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 10
Poland
- Earliest CTIS Part Ii Submission Date
- 17-06-2025
- Latest Decision Or Authorization Date
- 10-12-2025
- Processing Time Days
- 176
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- oddziat badan wczesnych faz
- Contact Person Name
- Iwona Ługowska
- Contact Person Email
- Iwona.Lugowska@nio.gov.pl
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Nectin Therapeutics Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Israel
Investigational products
- Investigational Product Name
- NTX-1088
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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