Clinical trial • Phase I • Oncology
BG-75098 for Advanced solid tumors|Ovarian cancer|Triple negative breast cancer|Hormone receptor positive HER2 negative breast cancer|Endometrial cancer|Gastric cancer|Prostate cancer|Bladder cancer|Small cell lung cancer|Gastroesophageal junction adenocarcinoma
Phase I trial of BG-75098 for Advanced solid tumors|Ovarian cancer|Triple negative breast cancer|Hormone receptor positive HER2 negative breast cancer|End…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors|Ovarian cancer|Triple negative breast cancer|Hormone receptor positive HER2 negative breast cancer|Endometrial cancer|Gastric cancer|Prostate cancer|Bladder cancer|Small cell lung cancer|Gastroesophageal junction adenocarcinoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 30-10-2025
- First CTIS Authorization Date
- 11-12-2025
Trial design
open-label, none/not specified-controlled Phase I trial in Denmark.
- Open Label
- Yes
- Comparator
- None/Not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 132
Eligibility
Recruits 132 Vulnerable population selected; no details on consent or assent handling provided..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided.
Recruitment
- Planned Sample Size
- 132
- Recruitment Window Months
- 60
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 15
Denmark
- Earliest CTIS Part Ii Submission Date
- 05-12-2025
- Latest Decision Or Authorization Date
- 11-12-2025
- Processing Time Days
- 6
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Rigshospitalet
- Department Name
- Phase 1 unit, Dept. of Oncology
- Principal Investigator Name
- Martin Martin Højgaard
- Principal Investigator Email
- martin.hoejgaard@regionh.dk
- Contact Person Name
- Martin Martin Højgaard
- Contact Person Email
- martin.hoejgaard@regionh.dk
- Number Of Participants
- 15
Sponsor
Primary sponsor
- Full Name
- BeOne Medicines I GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- BG-75098
- Combination Treatment
- Yes
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