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Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX) - Trial NCT06056310

Access comprehensive clinical trial information for NCT06056310 through Pure Global AI's free database. This Phase 1 trial is sponsored by EMD Serono Research & Development Institute, Inc. and is currently Not yet recruiting. The study focuses on Head and Neck Cancer. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06056310
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06056310
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Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX)

Study Focus

Head and Neck Cancer

Xevinapant

Interventional

drug

Sponsor & Location

EMD Serono Research & Development Institute, Inc.

EMD Serono

Billerica,Darmstadt, Germany,United States of America

Timeline & Enrollment

Phase 1

Jan 09, 2024

Apr 16, 2025

40 participants

Primary Outcome

Number of Participants with Dose limiting toxicity (DLT)-like events

Summary

The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added
 to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants
 with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for
 definitive chemoradiotherapy.

ICD-10 Classifications

Malignant neoplasm of other and ill-defined sites: Head, face and neck
Malignant neoplasm: Skin of scalp and neck
Malignant neoplasm: Connective and soft tissue of head, face and neck
Carcinoma in situ: Skin of scalp and neck
Secondary and unspecified malignant neoplasm: Lymph nodes of head, face and neck

Data Source

ClinicalTrials.gov

NCT06056310

Non-Device Trial