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

March 28, 2024 updated by: EMD Serono Research & Development Institute, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Edegem, Belgium
        • Recruiting
        • Uza - Parent
        • Principal Investigator:
          • Marika Rasschaert
      • Libramont, Belgium
        • Recruiting
        • Centre Hospitalier de l'Ardenne - PARENT
        • Principal Investigator:
          • Frédéric Forget
      • Sint Niklaas, Belgium
        • Recruiting
        • VITAZ
        • Principal Investigator:
          • Willem Lybaert
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
        • Principal Investigator:
          • Young Jin Choi
        • Contact:
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Keun-Wook Lee
      • Seoul, Korea, Republic of
        • Recruiting
        • Konkuk University Medical Center
        • Principal Investigator:
          • Ji-Hyun Park
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital Yonsei University Health System
        • Principal Investigator:
          • Hye Ryun Kim
      • Yangsan-si, Korea, Republic of
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Principal Investigator:
          • Jung Hoon Kim
  • Spain
      • Girona, Spain
        • Recruiting
        • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
        • Principal Investigator:
          • Jordi Rubio
      • Madrid, Spain
        • Recruiting
        • Clinica Universidad de Navarra (MAD) - Oncology Service
        • Principal Investigator:
          • Javier Serrano Andreu
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio - Oncology Service
        • Principal Investigator:
          • Maria Jose Flor Oncala
  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Principal Investigator:
          • Hui-Ching Wang
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Muh-Hwa Yang
  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
        • Principal Investigator:
          • Ragisha Gopalakrishnan
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute - PARENT
        • Principal Investigator:
          • Ammar W Sukari
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center PRIME
        • Contact:
        • Principal Investigator:
          • Rafi Kabarriti
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera McKennan Hospital and University Health Center
        • Principal Investigator:
          • Ryan A Vaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1
  • Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer [AJCC]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx
  • Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured
  • Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1.
  • Adequate hematological, hepatic, and renal function as defined in the protocol
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Primary tumor of nasopharyngeal, paranasal sinuses, nasal, or oral cavity, salivary, thyroid, or parathyroid gland pathologies, skin, or unknown primary site
  • Metastatic disease (Stage IVC as per AJCC/TNM, 8th Edition)
  • Existing need of a hearing aid or greater than or equal to (>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
  • Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded
  • Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption
  • Other protocol defined exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xevinapant + Cisplatin + IMRT
Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.
Drug: Cisplatin
Participants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2).
Radiation: intensity-modulated radiation therapy (IMRT)
Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week
Drug: Xevinapant
Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.
Other Names:
  • Debio 1143

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Dose limiting toxicity (DLT)-like events
Time Frame: From Day 1 up to 5 Weeks
From Day 1 up to 5 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs) and Treatment-Related AEs (TRAE)
Time Frame: From Day 1 up to 18 weeks (Each cycle is of 3 Weeks)
From Day 1 up to 18 weeks (Each cycle is of 3 Weeks)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 criteria as assessed by Investigator
Time Frame: Time from first administration of study intervention until Progressive Disease (PD) or death, whichever is earlier assessed approximately up to 1.6 years
Time from first administration of study intervention until Progressive Disease (PD) or death, whichever is earlier assessed approximately up to 1.6 years
Progression Free Survival (PFS) According to RECIST version 1.1 Criteria as Assessed by Investigator
Time Frame: Time from first administration of study intervention until PD or death, whichever is earlier assessed approximately up to 1.6 years
Time from first administration of study intervention until PD or death, whichever is earlier assessed approximately up to 1.6 years
Locoregional Control (LRC) According to RECIST version 1.1 Criteria As assessed by Investigator
Time Frame: From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or End of Study assessed approximately up to 1.6 years
LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes.
From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or End of Study assessed approximately up to 1.6 years
Time to Subsequent Systemic Cancer Treatments
Time Frame: From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or End of Study, assessed approximately up to 1.6 years
From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or End of Study, assessed approximately up to 1.6 years
Absolute values and changes in estimated glomerular filtration rate (eGFR)
Time Frame: From Screening up to Cycle 3 Day 4 (Day 67)
From Screening up to Cycle 3 Day 4 (Day 67)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, EMD Serono Research & Development Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 16, 2025

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS202359_0025
  • 2023-505796-76-00 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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