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Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer

NCT05245682 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-08

Study results available
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Summary

This early-phase trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past (previously untreated), has spread to nearby tissue or lymph nodes (locally advanced) and cannot receive cisplatin (cisplatin-ineligible). Tolinapant may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tolinapant and radiation therapy may kill more tumor cells.

Conditions

  • Head and Neck Carcinoma of Unknown Primary
  • Locally Advanced Head and Neck Squamous Cell Carcinoma
  • Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
  • Locally Advanced Laryngeal Squamous Cell Carcinoma
  • Locally Advanced Nasopharyngeal Squamous Cell Carcinoma
  • Locally Advanced Oropharyngeal Squamous Cell Carcinoma

Interventions

DRUG

Tolinapant

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Nicole C Schmitt, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2024-01-15
Completion
2026-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245682 on ClinicalTrials.gov