Clinical trial • Phase I • Other
PEP-010 for Recurrent and/or metastatic solid cancer
Phase I trial of PEP-010 for Recurrent and/or metastatic solid cancer. open-label, adaptive. 101 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Recurrent and/or metastatic solid cancer
- Trial Stage
- Phase I
- Drug Modality
- Peptide/protein/enzyme | Small molecule
Key dates
- Initial CTIS Submission Date
- 26-09-2024
- First CTIS Authorization Date
- 08-11-2024
Trial design
open-label, adaptive Phase I trial across 4 sites in France.
- Open Label
- Yes
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 101
Recruitment
- Planned Sample Size
- 101
- Recruitment Window Months
- 67
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 101
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 410
- Number Of Sites
- 4
- Number Of Participants
- 101
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncologie médicale - essais précoces
- Contact Person Name
- Sophie POSTEL-VINAY
- Contact Person Email
- sophie.postel-vinay@gustaveroussy.fr
- Site Name
- Institut Curie
- Department Name
- Oncologie médicale - essais précoces
- Contact Person Name
- Marie-Paule SABLIN
- Contact Person Email
- marie-paule.sablin@curie.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncologie médicale - essais précoces
- Contact Person Name
- Elodie COQUAN
- Contact Person Email
- e.coquan@baclesse.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncologie médicale - essais précoces
- Contact Person Name
- Sandrine HIRET
- Contact Person Email
- sandrine.hiret@ico.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Institut Curie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- PEP-010
- Active Substance
- PEP-010
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- intravenous
- Route
- intravenous
- First In Human
- Yes
- Investigational Product Name
- Paclitaxel
- Active Substance
- Paclitaxel
- Modality
- Small molecule
- Investigational Product Name
- Gemcitabine
- Active Substance
- Gemcitabine
- Modality
- Small molecule
- Combination Treatment
- Yes
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