Clinical Trials /

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

NCT04893551

Description:

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.

Related Conditions:
  • High Grade Ovarian Serous Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04893551

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: BGB149-102
  • SECONDARY ID: 2020-001382-36
  • NCT ID: NCT04893551

Conditions

  • Ovarian Neoplasms

Interventions

DrugSynonymsArms
TilvestamabBGB149Tilvestamab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
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.
  • Tilvestamab

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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse events (AEs) and Serious AEs (SAEs)
Time Frame:Up to 2.5 years
Safety Issue:
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.

Secondary Outcome Measures

Measure:Number of Participants with Anti-drug Antibodies (ADAs)
Time Frame:Up to 2.5 years
Safety Issue:
Description:Number of participants with ADAs will be reported.
Measure:Number of Participants with Neutralizing Antibodies (NAbs)
Time Frame:Up to 2.5 years
Safety Issue:
Description:Number of participants with NAbs will be reported.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BerGenBio ASA

Last Updated

May 19, 2021