Xevinapant (Debio 1143)

DRUG2 trials

Sponsors

EMD Serono Research & Development Institute, Inc., Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

HealthySquamous Cell Carcinoma of the Head and Neck

Phase 1

PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants

CompletedNCT05519540

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyHealthy

Start: 2022-09-26End: 2023-04-21Updated: 2025-08-20

Phase 3

A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

TerminatedNCT04459715

EMD Serono Research & Development Institute, Inc.Squamous Cell Carcinoma of the Head and Neck

Start: 2020-08-07End: 2024-09-18Updated: 2025-10-08

Related Papers

Abstract CT140: A phase 1 study of the IAP inhibitor xevinapant (Debio 1143) to evaluate food effect and drug-drug interactions with a proton pump inhibitor in healthy volunteers

Cancer Research2024-04-05

Effect of extended treatment with IAP inhibitor xevinapant post radiotherapy (RT) on efficacy and the tumor microenvironment (TME) in preclinical models.

Journal of Clinical Oncology2023-06-012 citations

Leveraging the mechanism of action (MOA) of xevinapant, an IAP inhibitor, for phase 3 dosing (RP3D) strategies in combination with radiation (RT) and chemoradiotherapy (CRT) in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).

Journal of Clinical Oncology2023-06-01

Abstract 5424: Selection of RP3D of xevinapant in combination with CRT in patients with LA SCCHN

Cancer Research2022-06-151 citations

Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design

Future Oncology2022-02-1727 citations

TrilynX: A phase 3 trial of xevinapant and concurrent chemoradiation for locally advanced head and neck cancer.

Journal of Clinical Oncology2021-05-208 citations