drugset / Trial / NCT03386721
Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.
Timeline
- Start
- 2018-02-19
- Primary completion
- 2021-12-30
- Completion
- 2021-12-30
Outcome
Outcome not reported
Stopped (Business): “The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.”
Publications
- Verlingue L, Italiano A, Prenen H, Guerra Alia EM, Tosi D, Perets R, Lugowska I, Moiseyenko V, Gumus M, Arslan C, Lindsay CR, Deva S, Taus A, Oaknin A, Rottey S, Cicin I, Goksu SS, Smolin A, Rosello-Keranen S, Habigt C, Marbach D, Boetsch C, Dejardin D, Sleiman N, Evers S, Richard M, Ardeshir C, Charo J, Kraxner A, Teichgraber V, Keshelava N, Dziadziuszko R. Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. EBioMedicine. 2024 Nov;109:105374. doi: 10.1016/j.ebiom.2024.105374. Epub 2024 Oct 11.
- Prenen H, Deva S, Keam B, Lindsay CR, Lugowska I, Yang JC, Longo F, de Miguel M, Ponz-Sarvise M, Ahn MJ, Gumus M, Champiat S, Italiano A, Salas S, Perets R, Arslan C, Cho BC, Evers S, Boetsch C, Marbach D, Dejardin D, Sleiman N, Ardeshir C, Richard M, Charo J, Kraxner A, Keshelava N, Teichgraber V, Moreno V. Phase II Study to Determine the Antitumor Activity and Safety of Simlukafusp Alfa (FAP-IL2v) Combined with Atezolizumab in Esophageal Cancer. Clin Cancer Res. 2024 Jul 15;30(14):2945-2953. doi: 10.1158/1078-0432.CCR-23-2677.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 840 mg | Intravenous |
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Vinorelbine | Small molecule | — | — |
| Subject | simlukafusp alfa | Protein / enzyme biologic | 10 mg | Intravenous |
Indications
No indication recorded.