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NCT06056310Not yet recruiting

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)
EMD Serono Research & Development Institute, Inc.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Head and Neck Cancer
Drug/Device/Intervention
Xevinapant
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
EMD Serono Research & Development Institute, Inc.
Funder
EMD Serono
Location
Billerica,Darmstadt, Germany,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jan 09, 2024
End date
Apr 16, 2025
Enrollment
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 neckMalignant neoplasm: Skin of scalp and neckMalignant neoplasm: Connective and soft tissue of head, face and neckCarcinoma in situ: Skin of scalp and neckSecondary and unspecified malignant neoplasm: Lymph nodes of head, face and neck
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06056310
Type
Non-Device Trial
About this record

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.