Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors

Summary

This was a single arm phase Ib study to evaluate the safety and efficacy of combined Tomuzotuximab and Gatipotuzumab therapy in patients with metastatic solid tumors expressing EGFR for whom no standard treatment is available. Patients who had relapsed following their most recent line of chemotherapy and who met all other entry criteria at Screening were enrolled to receive Tomuzotuximab and Gatipotuzumab in combination. During the extension phase, instead of Tomuzotuximab a commercially avalaible anti-EGFR antibody, i.e. Cetuximab (including any approved biosimilar), Panitumumab, or Necitumumab could be given to patients with cancers for which their use is approved.

Timeline

Start

2017-11-02

Primary completion

2020-05-04

Completion

2020-09-29

Publications

• Ochsenreither S, Fiedler WM, Conte GD, Macchini M, Matos I, Habel B, Ahrens-Fath I, Raspagliesi F, Lorusso D, Keilholz U, Rolling C, Kebenko M, Klinghammer KF, Saavedra O, Baumeister H, Zurlo A, Garralda E. Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors. ESMO Open. 2022 Apr;7(2):100447. doi: 10.1016/j.esmoop.2022.100447. Epub 2022 Apr 6.

Drugs

Indications