Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07156227
Phase
PHASE1
Status
Recruiting
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Conditions

  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Recurrent Paranasal Sinus Squamous Cell Carcinoma
  • Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
  • Stage III Hypopharyngeal Carcinoma AJCC v8
  • Stage III Laryngeal Cancer AJCC v8
  • Stage III Lip and Oral Cavity Cancer AJCC v8
  • Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage III Sinonasal Cancer AJCC v8
  • Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
  • Stage IVA Hypopharyngeal Carcinoma AJCC v8
  • Stage IVA Laryngeal Cancer AJCC v8
  • Stage IVA Lip and Oral Cavity Cancer AJCC v8
  • Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVA Sinonasal Cancer AJCC v8
  • Stage IVB Hypopharyngeal Carcinoma AJCC v8
  • Stage IVB Laryngeal Cancer AJCC v8
  • Stage IVB Lip and Oral Cavity Cancer AJCC v8
  • Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVB Sinonasal Cancer AJCC v8
  • Unresectable Head and Neck Squamous Cell Carcinoma
  • Unresectable Hypopharyngeal Squamous Cell Carcinoma
  • Unresectable Laryngeal Squamous Cell Carcinoma
  • Unresectable Oral Cavity Squamous Cell Carcinoma
  • Unresectable Oropharyngeal Squamous Cell Carcinoma
  • Unresectable Paranasal Sinus Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Camonsertib — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

This phase I trial tests the safety, side effects, and best dose of camonsertib in combination with stereotactic body radiation therapy in controlling disease in patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that cannot be removed by surgery (unresectable). Camonsertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving camonsertib in combination with stereotactic body radiation therapy may help control disease in patients with recurrent or unresectable head and neck squamous cell cancers.

Key Dates

Start date
Feb 13, 2027
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (camonsertib, SBRT)
    Patients undergo 4 or 5 treatment fractions of SBRT twice weekly, 2-3 days apart between fractions, over 3 weeks. Patients receive camonsertib PO QD on the day of and the day after each radiation therapy treatment. Patients also undergo PET/CT or CT and collection of blood samples throughout the trial.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: During dose escalation phase ]

Locations (1)

FacilityCityStateZIP
UPMC Hillman Cancer Center LAOPittsburghPennsylvania15232

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UPMC Hillman Cancer Center LAO· Pittsburgh, PA

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