drugset / Trial / NCT05256381

A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors

NCT05256381 ↗

Phase 2 Terminated 166 enrolled SOTIO Biotech AG Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors.

Timeline

Start
2022-06-21
Primary completion
2024-08-31
Completion
2024-11-29

Outcome

Missed primary endpoint

Stopped: “Due to lack of expected 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

EvaluationDrugModalityDoseRoute
Subject Nanrilkefusp alfa Protein / enzyme biologic 12 ug/kg Subcutaneous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous