drugset / Trial / NCT06056310
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
Phase 1
Terminated
18 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-01-18
- Primary completion
- 2024-08-20
- Completion
- 2024-08-20
Outcome
Outcome not reported
Stopped: “No major safety concerns were identified in HyperlynX study, but Lack of evidence of efficacy of meaningful clinical benefit.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xevinapant | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |