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

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.

Timeline

Start

2021-02-25

Primary completion

2022-06-27

Completion

2022-06-27

Outcome

Outcome not reported

Stopped (Business): “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.”

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.

Drugs

Indications