A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer

Summary

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer.

Timeline

Start

2022-12-22

Primary completion

2024-03-06

Completion

2024-06-05

Outcome

Missed primary endpoint

Stopped: “Due to lack of efficacy shown at the time of the interim analysis.”

release “Interim data from SOTIO’s clinical trials of nanrilkefusp alfa have shown insufficient efficacy to warrant further development in larger randomized trials in these specific indications and combinations.” sotio.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nanrilkefusp alfa	Protein / enzyme biologic	9 ug/kg	Subcutaneous
Subject	Nanrilkefusp alfa	Protein / enzyme biologic	12 ug/kg	Subcutaneous
Background	Cetuximab	Monoclonal antibody	—	Intravenous

Indications