A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

Summary

This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

Timeline

Start

2015-12-07

Primary completion

2022-11-10

Completion

2022-11-10

Publications

• Hansen AR, Gomez-Roca CA, Robbrecht DGJ, Verlingue L, Italiano A, Bauman JE, Steeghs N, Prenen H, Fayette J, Spicer J, Niu J, Habigt C, Schneider M, Evers S, Sleiman N, Dejardin D, Ardeshir C, Schmid D, Boetsch C, Charo J, Kraxner A, Teichgraber V, Keshelava N, Bonomi MR. Phase Ib Study of the Immunocytokine Simlukafusp Alfa (FAP-IL2v) in Combination with Cetuximab in Patients with Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2024 Dec 16;30(24):5540-5547. doi: 10.1158/1078-0432.CCR-24-1562.

Drugs

Indications