A randomized double-blind placebo-controlled Phase 3 study of Debio 1143 in combo w/ platinum-based chemo & standard fractionation intensitymodulated radiotherapy in patients w/ locally advanced HNSCC suitable for definitive chemoradiotherapy

Brief description of study

The purpose of the study is to compare the efficacy and safety of Debio 1143 versus matched placebo, when administered in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy (IMRT) in previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN), suitable for definitive chemoradiotherapy (CRT). Debio 1143 is an oral solution that acts as an antagonist of IAPs (inhibitor of apoptosis proteins) that is being evaluated to see if it may sensitize tumor cells to CRT by promoting apoptosis (programmed cell death) and fostering antitumor immunity. Debio 1143 was granted breakthrough therapy designation by the FDA in early 2020. The study drug Debio 1143 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.

Clinical Study Identifier: s20-00414
ClinicalTrials.gov Identifier: NCT04459715

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