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

Primary Purpose

Ovarian Neoplasms

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tilvestamab
Sponsored by
BerGenBio ASA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Samsung Medical Center
  • Seoul National University Hospital
  • Yonsei University Health System- Severance Hospital
  • Haukeland University Hospital Bergen
  • National University Hospital
  • Western General Hospital
  • Guys and St Thomas' NHS Foundation Trust
  • Imperial College London, Hammersmith Hospital
  • Churchill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tilvestamab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with resting triplicate 12-lead ECG abnormalities will be reported.
Number of Participants with Physical Examinations Abnormalities
Number of participants with physical examinations abnormalities will be reported.
Number of Participants with Concomitant Medication Use
Number of participants with concomitant medication use will be reported.
Maximum Concentration (Cmax)
Cmax will be determined directly from the concentration-time profile.
Time to Cmax (Tmax)
Time to Cmax will be determined directly from the concentration-time profile.
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.
AUC From Predose (Time 0) to the Time of the Last Quantifiable Concentration (AUClast)
AUClast will be calculated using the linear-log trapezoidal rule.
AUC From Predose (Time 0) to 168 Hours Postdose (AUC0-168 )
AUC0-168 is AUC from predose (time 0) to 168 hours postdose.
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.
Terminal Elimination Half-life
Terminal elimination half-life calculated as: ln2/Lambda[z]
Total body clearance (CL)
CL is defined as total body clearance.

Secondary Outcome Measures

Number of Participants with Anti-drug Antibodies (ADAs)
Number of participants with ADAs will be reported.
Number of Participants with Neutralizing Antibodies (NAbs)
Number of participants with NAbs will be reported.

Full Information

First Posted
May 17, 2021
Last Updated
April 18, 2023
Sponsor
BerGenBio ASA
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1. Study Identification

Unique Protocol Identification Number
NCT04893551
Brief Title
A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
June 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BerGenBio ASA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tilvestamab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Tilvestamab
Other Intervention Name(s)
BGB149
Intervention Description
Tilvestamab will be administered as IV infusion.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse events (AEs) and Serious AEs (SAEs)
Description
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.
Time Frame
Up to 2.5 years
Title
Number of Participants with Laboratory Abnormalities
Description
Number of participants with laboratory (haematology, coagulation, clinical chemistry, serum inflammatory cytokine profile, and urinalysis) abnormalities will be reported.
Time Frame
Up to 2.5 years
Title
Number of Participants with Vital Sign Abnormalities
Description
Number of participants with vital sign (supine blood pressure [BP], heart rate, oral temperature, and respiratory rate) abnormalities will be reported.
Time Frame
Up to 2.5 years
Title
Number of Participants with Electrocardiogram (ECG) Abnormalities
Description
Number of participants with resting triplicate 12-lead ECG abnormalities will be reported.
Time Frame
Up to 2.5 years
Title
Number of Participants with Physical Examinations Abnormalities
Description
Number of participants with physical examinations abnormalities will be reported.
Time Frame
Up to 2.5 years
Title
Number of Participants with Concomitant Medication Use
Description
Number of participants with concomitant medication use will be reported.
Time Frame
Up to 2.5 years
Title
Maximum Concentration (Cmax)
Description
Cmax will be determined directly from the concentration-time profile.
Time Frame
Up to 140 days
Title
Time to Cmax (Tmax)
Description
Time to Cmax will be determined directly from the concentration-time profile.
Time Frame
Up to 140 days
Title
Area Under the Concentration-time Curve (AUC) From Predose (Time 0) to the end of the Dosing Period (AUC0-tau)
Description
AUC0-tau will be calculated using the linear-log trapezoidal rule.
Time Frame
Up to 140 days
Title
AUC From Predose (Time 0) to the Time of the Last Quantifiable Concentration (AUClast)
Description
AUClast will be calculated using the linear-log trapezoidal rule.
Time Frame
Up to 140 days
Title
AUC From Predose (Time 0) to 168 Hours Postdose (AUC0-168 )
Description
AUC0-168 is AUC from predose (time 0) to 168 hours postdose.
Time Frame
Predose up to 168 hours postdose
Title
Terminal Elimination Rate Constant (Lambda[z])
Description
Lambda[z] will be determined by selection of at least 3 data points on the terminal phase of the concentration-time curve.
Time Frame
Up to 140 days
Title
Terminal Elimination Half-life
Description
Terminal elimination half-life calculated as: ln2/Lambda[z]
Time Frame
Up to 140 days
Title
Total body clearance (CL)
Description
CL is defined as total body clearance.
Time Frame
Up to 140 days
Secondary Outcome Measure Information:
Title
Number of Participants with Anti-drug Antibodies (ADAs)
Description
Number of participants with ADAs will be reported.
Time Frame
Up to 2.5 years
Title
Number of Participants with Neutralizing Antibodies (NAbs)
Description
Number of participants with NAbs will be reported.
Time Frame
Up to 2.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akil Jackson
Organizational Affiliation
BerGenBio ASA
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Health System- Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Haukeland University Hospital Bergen
City
Bergen
Country
Norway
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Guys and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Imperial College London, Hammersmith Hospital
City
London
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the article, after deidentification [text, tables, figures and appendices].
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Proposal should be directed to HYPERLINK "mailto:clinical@bergenbio.com" clinical@bergenbio.com. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

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

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