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

NCT04893551 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-04-20

No results posted yet for this study

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.

Conditions

  • Ovarian Neoplasms

Interventions

BIOLOGICAL

Tilvestamab

Tilvestamab will be administered as IV infusion.

Sponsors & Collaborators

  • BerGenBio ASA

    lead INDUSTRY

Principal Investigators

  • Akil Jackson · BerGenBio ASA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2022-06-27
Completion
2022-06-27

Countries

  • Norway
  • Singapore
  • South Korea
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04893551 on ClinicalTrials.gov