Trials / Terminated
TerminatedNCT04893551
A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- BerGenBio ASA · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tilvestamab | Tilvestamab will be administered as IV infusion. |
Timeline
- Start date
- 2021-02-25
- Primary completion
- 2022-06-27
- Completion
- 2022-06-27
- First posted
- 2021-05-19
- Last updated
- 2023-04-20
Locations
9 sites across 4 countries: Norway, Singapore, South Korea, United Kingdom
Source: ClinicalTrials.gov record NCT04893551. Inclusion in this directory is not an endorsement.