Testing Camonsertib with Radiation for Recurrent Head and Neck Cancer
This study is testing a new approach for people with head and neck squamous cell cancer that has come back (recurrent) or cannot be removed by surgery. It combines an anti-cancer drug called Camonsertib with Stereotactic Body Radiation Therapy (SBRT), a precise type of radiation. Camonsertib works by blocking enzymes that cancer cells need to grow. The main goals are to find out if this combination is safe, what side effects it might cause, and the best dose of Camonsertib to use with SBRT. Researchers will also look at how well the treatment shrinks tumors and prevents the cancer from growing. You may be eligible if you are 18 or older and have recurrent head and neck squamous cell carcinoma.
- Study design
- This is a Phase 1 interventional study, meaning it's an early-stage trial to test safety and dosage. It plans to enroll 39 participants.
- What's involved
- You would undergo blood sample collection, CT or PET/CT scans, and receive Camonsertib by mouth daily on radiation treatment days. You would also receive Stereotactic Body Radiation Therapy (SBRT) twice weekly over three weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for late side effects within one year of starting treatment.
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NCT07156227
Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~39 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCamonsertibComputed TomographyPositron Emission TomographyStereotactic Body Radiation Therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over During dose escalation phase
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Yvonne M Mowery · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center LAO
Who to contact
Site Public Contact
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients must have histologically confirmed recurrent or metachronous (second primary) unresectable head and neck squamous cell carcinoma involving the oral cavity, oropharynx, larynx, hypopharynx, and/or paranasal sinus, or cervical lymphadenopathy with unknown primary. Core needle biopsy (preferably at least three 18-gauge cores) or incisional biopsy is preferred over fine needle aspiration (FNA) for diagnosis of recurrent disease or new primary head and neck squamous cell carcinoma to provide sufficient tumor tissue for correlative studies. Unresectable refers both to patients who have declined surgery and patients deemed unresectable by otolaryngology. This includes patients for whom curative resection is medically contraindicated and/or would be associated with excessive surgical risk (as deemed by the consulting otolaryngologist) or undue surgical morbidity (e.g., total glossectomy, laryngectomy, and/or major resection requiring free flap reconstruction). There are no requirements related to prior systemic therapies that patients may have received
Patients must have recurrent disease within a previously irradiated area (radiotherapy to dose ≥ 30 gray \[Gy\] and ≤ 80 Gy; in-field recurrence)
Patients must have completed prior radiotherapy at least 6 months prior to enrollment. Due to safety concerns, reirradiation within less than 6 months to the head and neck is very rarely recommended per standard of care
Patients must have measurable disease (at least one measurable lesion) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Baseline imaging must include neck CT (preferably contrast-enhanced) and chest CT or skullbase to midthigh PET/CT (preferably with contrast-enhanced neck CT if diagnostic contrast-enhanced neck CT not available). Patients who have undergone surgery aside from biopsy may be included if gross disease is present within the surgical resection bed or at another site
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of camonsertib in combination with radiotherapy in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Leukocyte count ≥ 3,000/mcL
Absolute neutrophil count ≥ 1,500/mcL
Platelets ≥ 100,000/mcL
Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin dependency (within 7 days of assessment)
Serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (if total serum bilirubin \> 1.5 × institutional ULN, then direct bilirubin must be \< ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 × institutional ULN
Albumin \> 2.5 mg/dL
Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2
GFR can be measured directly or estimated using the site's institutional standards
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
Ability to take pills by mouth
The effects of camonsertib on the developing human fetus are unknown. For this reason and because ATR inhibitors and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of camonsertib administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia
Patients who are receiving any other investigational agents for a current cancer diagnosis
Patients with distant metastatic disease
Patients who have received more than one prior course of head and neck radiotherapy overlapping the region to be treated with the current diagnosis of head and neck cancer
Patients who have disease surrounding \> 180 degrees of the carotid artery
Patients with tumors invading the mandible or tumors with gross skin involvement (i.e., tumor ulceration through the skin)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to camonsertib or radiation
Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
Pregnant women are excluded from this study because camonsertib is an ATR inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with camonsertib, breastfeeding should be discontinued if the mother is treated with camonsertib. These potential risks may also apply to other agents used in this study
Patients diagnosed with scleroderma
Concomitant use of strong CYP3A4/5 inhibitors and inducers, and strong P-gp and BCRP inhibitors
Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
What this trial measures
- Incidence of adverse events (AEs)During dose escalation phase
The safety and tolerability of camonsertib will be evaluated during the dose escalation phase. The frequency and percentage of AEs will be provided overall and by dose level for any grade and attribution as well as for grade 3 or greater AEs, at least possibly related to treatment.
- Maximum tolerated dose (MTD) of camonsertib and concurrent stereotactic body radiation therapy (SBRT) reirradiationDuring dose escalation phase
The dose-escalation phase will utilize a Bayesian Optimal Interval Design to determine the MTD for combined camonsertib and SBRT.
- Incidence of late toxicities (dose expansion phase)Within 1 year of treatment initiation
The proportions of total patients experiencing late toxicities will be estimated. The frequency and percentage of AEs will be provided overall and by dose level for any grade and attribution as well as for grade 3 or greater AEs, at least possibly related to treatment.