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Ovarian NeoplasmsPhase 1NCT04893551

A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants

A Phase 1 study testing Tilvestamab in people with Ovarian Neoplasms, run by BerGenBio ASA at 9 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 course of platinum-based chemotherapy and whose disease has relapsed with platinum resistance ([PRR]-HGSOC) and to… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
Tilvestamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
9 sitesin 4 countries
Study dates
25 Feb 2021to 27 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

United Kingdom4 sites

  • Western General Hospital

    Edinburgh

  • Guys and St Thomas' NHS Foundation Trust

    London

  • Imperial College London, Hammersmith Hospital

    London

  • Churchill Hospital

    Oxford

Other trials in United Kingdom

South Korea3 sites

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Yonsei University Health System- Severance Hospital

    Seoul

Other trials in South Korea

Norway1 site

  • Haukeland University Hospital Bergen

    Bergen

Other trials in Norway

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

Official title: Phase 1b, Multicentre, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Patients

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 course of platinum-based chemotherapy and whose disease has relapsed with platinum resistance ([PRR]-HGSOC) and to determine the plasma pharmacokinetics (PK) exposure by comprehensive profiling (at single dose and steady-state) of multiple ascending doses of tilvestamab.

Being tested
Tilvestamab
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TilvestamabBiological

    Also called BGB149

    Tilvestamab will be administered as IV infusion.

Study groups in NCT04893551
Study groupRoleWhat they receive
TilvestamabExperimentalParticipants 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.
Receives: Biological: Tilvestamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse events (AEs) and Serious AEs (SAEs)

    An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Up to 2.5 years

  2. Number of Participants with Laboratory Abnormalities

    Number of participants with laboratory (haematology, coagulation, clinical chemistry, serum inflammatory cytokine profile, and urinalysis) abnormalities will be reported.

    Measured: Up to 2.5 years

  3. Number of Participants with Vital Sign Abnormalities

    Number of participants with vital sign (supine blood pressure [BP], heart rate, oral temperature, and respiratory rate) abnormalities will be reported.

    Measured: Up to 2.5 years

  4. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Number of participants with resting triplicate 12-lead ECG abnormalities will be reported.

    Measured: Up to 2.5 years

  5. Number of Participants with Physical Examinations Abnormalities

    Number of participants with physical examinations abnormalities will be reported.

    Measured: Up to 2.5 years

  6. Number of Participants with Concomitant Medication Use

    Number of participants with concomitant medication use will be reported.

    Measured: Up to 2.5 years

  7. Maximum Concentration (Cmax)

    Cmax will be determined directly from the concentration-time profile.

    Measured: Up to 140 days

  8. Time to Cmax (Tmax)

    Time to Cmax will be determined directly from the concentration-time profile.

    Measured: Up to 140 days

  9. Area Under the Concentration-time Curve (AUC) From Predose (Time 0) to the end of the Dosing Period (AUC0-tau)

    AUC0-tau will be calculated using the linear-log trapezoidal rule.

    Measured: Up to 140 days

  10. AUC From Predose (Time 0) to the Time of the Last Quantifiable Concentration (AUClast)

    AUClast will be calculated using the linear-log trapezoidal rule.

    Measured: Up to 140 days

  11. AUC From Predose (Time 0) to 168 Hours Postdose (AUC0-168 )

    AUC0-168 is AUC from predose (time 0) to 168 hours postdose.

    Measured: Predose up to 168 hours postdose

  12. Terminal Elimination Rate Constant (Lambda[z])

    Lambda[z] will be determined by selection of at least 3 data points on the terminal phase of the concentration-time curve.

    Measured: Up to 140 days

  13. Terminal Elimination Half-life

    Terminal elimination half-life calculated as: ln2/Lambda[z]

    Measured: Up to 140 days

  14. Total body clearance (CL)

    CL is defined as total body clearance.

    Measured: Up to 140 days

Secondary outcomes (2)

  1. Number of Participants with Anti-drug Antibodies (ADAs)

    Number of participants with ADAs will be reported.

    Measured: Up to 2.5 years

  2. Number of Participants with Neutralizing Antibodies (NAbs)

    Number of participants with NAbs will be reported.

    Measured: Up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start25 Feb 2021
  3. Primary completion27 Jun 2022
  4. Study completion27 Jun 2022

Why it stopped: After completion of all planned dose levels in the dose escalation phase, the sponsor decision was not to continue with expanding the cohorts of any of the dose levels, using the existing study design.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893551
Sponsor's protocol ID
BGB149-102
Other IDs
2020-001382-36
Status last verified
Apr 2023
First submitted
17 May 2021
Last updated
20 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in the article, after deidentification \[text, tables, figures and appendices\].

Publications

  • 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.

    PubMed 40696160

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tilvestamab in people with Ovarian Neoplasms, run by BerGenBio ASA at 9 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom, South Korea, Norway, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: After completion of all planned dose levels in the dose escalation phase, the sponsor decision was not to continue with expanding the cohorts of any of the dose levels, using the existing study design.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse events (AEs) and Serious AEs (SAEs) (time frame: Up to 2.5 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04893551, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.

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