Clinical trial • Phase I/II • Oncology
STAR0602 for Unresectable locally advanced or metastatic solid tumors
Phase I/II trial of STAR0602 for Unresectable locally advanced or metastatic solid tumors. open-label, adaptive. 225 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Unresectable locally advanced or metastatic solid tumors
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 01-09-2023
- First CTIS Authorization Date
- 11-01-2024
Trial design
open-label, adaptive Phase I/II trial across 2 sites in Spain, France.
- Open Label
- Yes
- Adaptive
- True, dose escalation and expansion design (no detailed adaptive rules provided)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 225
Recruitment
- Planned Sample Size
- 225
- Recruitment Window Months
- 32
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 46
Spain
- Earliest CTIS Part Ii Submission Date
- 22-11-2023
- Latest Decision Or Authorization Date
- 11-01-2024
- Processing Time Days
- 50
- Number Of Sites
- 1
- Number Of Participants
- 23
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Elena Garralda
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda
- Contact Person Email
- egarralda@vhio.net
- Number Of Participants
- 23
France
- Earliest CTIS Part Ii Submission Date
- 27-11-2023
- Latest Decision Or Authorization Date
- 15-01-2024
- Processing Time Days
- 49
- Number Of Sites
- 1
- Number Of Participants
- 23
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP
- Principal Investigator Name
- Stephane Champiat
- Principal Investigator Email
- stephane.champiat@gustaveroussy.fr
- Contact Person Name
- Stephane Champiat
- Contact Person Email
- stephane.champiat@gustaveroussy.fr
- Number Of Participants
- 23
Sponsor
Primary sponsor
- Full Name
- Marengo Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- STAR0602
- Modality
- Bispecific antibody
- First In Human
- Yes
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