A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

Summary

This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  FT825

  FT825 will be administered as an intravenous (IV) infusion at planned dose levels.

• Drug
  Fludarabine

  Fludarabine will be administered as an IV infusion at planned dose levels.

• Drug
  Cyclophosphamide

  Cyclophosphamide will be administered as an IV infusion at planned dose levels.

• Drug
  Bendamustine

  Bendamustine will be administered as an IV infusion at planned dose levels.

• Drug
  Docetaxel

  Docetaxel will be administered as an IV infusion at planned dose levels.

• Drug
  Cisplatin

  Cisplatin will be administered as an IV infusion at planned dose levels.

• Drug

Locations (14)