Actively Recruiting
Phase I Trial of ATR Inhibitor Camonsertib Combined With Stereotactic Body Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-06-03
39
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying camonsertib, an anti-cancer drug, combined with stereotactic body radiation therapy (SBRT) in patients with recurrent or unresectable head and neck squamous cell carcinoma. This phase I trial aims to evaluate the safety, side effects, and the best dose of camonsertib when used along with precise radiation treatment to control tumor growth in these patients. The study also explores biomarkers to predict response and how the body processes camonsertib. Participants receive 4 or 5 doses of SBRT twice weekly over three weeks, with 2 to 3 days between radiation sessions. Camonsertib is taken orally once daily on the day of and the day following each radiation treatment. The study includes dose escalation followed by dose expansion to identify the recommended dose. Throughout the trial, patients undergo imaging scans like PET/CT or CT and have blood samples collected. During and after treatment, patients are monitored regularly with follow-up visits at weeks 4, 5, 6, 7, 16, 29, 42, and 55. Researchers measure outcomes including side effects, tumor response within the radiation field, progression-free survival, and late toxicities up to one year after treatment starts. The study tracks both safety and effectiveness signals over this period.
CONDITIONS
Brief Title
Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed recurrent or new primary unresectable head and neck squamous cell carcinoma involving specified areas
- Recurrent disease must be within a previously irradiated area with radiation dose between 30 and 80 Gy
- Prior radiotherapy completed at least 6 months before enrollment
- Measurable disease by RECIST version 1.1 with baseline imaging available
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky score of 60% or higher)
- Adequate blood counts: leukocytes, neutrophils, platelets, and hemoglobin
- Liver function within specified limits
- Albumin level greater than 2.5 mg/dL
- Glomerular filtration rate of 60 mL/min/1.73 m2 or higher
- HIV positive patients on effective therapy with undetectable viral load within 6 months
- Patients with controlled hepatitis B or cured hepatitis C
- Prior or concurrent malignancy allowed if it does not interfere with study assessments
- Cardiac function classified as New York Heart Association class II or better
- Ability to take oral medication
- Agreement to use contraception during and 6 months after study participation
- Ability and willingness to provide informed consent
You will not qualify if you...
- Patients with unresolved side effects from prior cancer therapy greater than grade 1, except alopecia
- Use of other investigational agents for current cancer
- Presence of distant metastatic disease
- More than one prior course of head and neck radiotherapy overlapping current treatment area
- Disease surrounding more than 180 degrees of the carotid artery
- Tumors invading the mandible or with gross skin involvement
- Allergic reactions to similar compounds as camonsertib or radiation
- Uncontrolled illnesses or significant conditions making participation risky
- Pregnant or breastfeeding women
- Diagnosis of scleroderma
- Use of strong CYP3A4/5 or P-gp and BCRP inhibitors or inducers that could interact with study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive camonsertib orally once daily on the day of and the day after each radiation therapy treatment while undergoing 4 or 5 fractions of stereotactic body radiation therapy (SBRT) twice weekly over 3 weeks. Participants also undergo PET/CT or CT scans and blood sample collection throughout this period.
4 to 5 treatment visits (in-person) twice weekly and additional visits for imaging and blood samples
Duration - Up to 55 weeks
After completing treatment, participants are followed up to monitor safety and treatment outcomes.
Visits at weeks 4, 5, 6, 7, 16, 29, 42, and 55
Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center LAO
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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