Status:
TERMINATED
A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants
Lead Sponsor:
BerGenBio ASA
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The primary purpose is to assess the safety and tolerability of tilvestamab following IV administration of multiple doses to participants with HGSOC who have been treated with at least 1 complete cour...
Eligibility Criteria
Inclusion
- Females of non-childbearing potential at the time of provision of informed consent
- Ability to understand and provide written confirmation of informed consent after reading study information, discussion with the investigator, and adequate time to decide on participation
- Consents to storage of study-related samples and data for exploratory use
- Histologically confirmed HGSOC
- Platinum-resistant relapsed disease; defined as progressive disease based on imaging within \<= 6 months from completion of most recent regimen
Exclusion
- Primary platinum-refractory disease (ie, progression during the first platinum regimen or within 4 weeks of completion of the first platinum regimen) with rapid progression and life-threatening disease manifestation
- Life expectancy \< 6 months
- Concurrent anticancer therapy
- Participants who are breastfeeding
- Known uncontrolled central nervous system metastases. Participants without known brain metastases do not require radiological imaging prior to enrolment
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04893551
Start Date
February 25 2021
End Date
June 27 2022
Last Update
April 20 2023
Active Locations (9)
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1
Haukeland University Hospital Bergen
Bergen, Norway
2
National University Hospital
Singapore, Singapore
3
Samsung Medical Center
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea