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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