A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants
NCT ID: NCT04893551
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
16 participants
INTERVENTIONAL
2021-02-25
2022-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Tilvestamab
Participants will receive tilvestamab at a low starting dose level (Cohort A) given via intravenous (IV) infusion every 2 weeks. Dose escalations to subsequent cohorts (Cohort B and Cohort C) will be decided by the Protocol Steering Committee (PSC) after review of all Cycle 1 (28 days cycle) safety and pharmacokinetics (PK) data up to Cycle 1 Day 22 for all participants in the ongoing cohort.
Tilvestamab
Tilvestamab will be administered as IV infusion.
Interventions
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Tilvestamab
Tilvestamab will be administered as IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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BerGenBio ASA
INDUSTRY
Responsible Party
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Principal Investigators
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Akil Jackson
Role: STUDY_DIRECTOR
BerGenBio ASA
Locations
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Haukeland University Hospital Bergen
Bergen, , Norway
National University Hospital
Singapore, , Singapore
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System- Severance Hospital
Seoul, , South Korea
Western General Hospital
Edinburgh, , United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, , United Kingdom
Imperial College London, Hammersmith Hospital
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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References
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Sooi K, Tan TZ, Kim JW, Lee JY, Kim BG, Micklem D, Jackson A, Pinato DJ, Gourley C, Kristeleit R, Blagden SP, Bjorge L, Tan DSP. A phase 1b, multicentre, dose escalation, safety and pharmacokinetics study of tilvestamab (BGB149) in relapsed, platinum-resistant, high-grade serous ovarian cancer (PROC) patients. Br J Cancer. 2025 Oct;133(6):896-908. doi: 10.1038/s41416-025-03090-6. Epub 2025 Jul 22.
Other Identifiers
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2020-001382-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BGB149-102
Identifier Type: -
Identifier Source: org_study_id
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