SillaJen Seeks FDA Clearance to Modify BAL0891 Trial to Target Urothelial Cancer
Bitget2026/11/05 07:18- SillaJen filed a US FDA application on Nov. 5, 2026, to amend its Phase 1 trial of BAL0891.
- The amendment would focus Part 2 dose expansion on BAL0891 with paclitaxel for unresectable, locally advanced or metastatic urothelial cancer.
- Earlier trial results informed the proposed change in the Part 2 target disease.
- The expansion will assess preliminary antitumor activity, safety and tolerability once a recommended combination dose is selected.
- The overall trial targets approximately 200 participants, with completion scheduled for June 2029.
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