Phase 1 Head and Neck Cancer Trial, Recruiting NCT07156227 Sponsor: National Cancer Institute (NCI) Condition: Head and Neck Cancer
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Phase 1 Head and Neck Cancer Trial, Recruiting

NCT07156227
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with head and neck squamous cell cancer (in the mouth, throat, voice box, or nearby areas) that has come back or is a new cancer in the same region, and cannot be removed by surgery — either because you declined surgery or a specialist determined surgery is not possible or safe.
  • Your cancer has come back in an area of your body that was previously treated with radiation therapy.
  • You finished your previous radiation treatment at least 6 months before joining this trial.
  • You have at least one measurable tumor that can be seen on a scan (such as a CT or PET scan).
  • You are 18 years of age or older.
  • You are well enough to carry out basic daily activities (your doctor can confirm this using a standard health scale).
  • Your blood cell counts are at healthy enough levels — including white blood cells, infection-fighting cells (neutrophils), platelets, and red blood cells — as shown by recent blood tests.
  • Your liver is functioning well enough, as shown by blood test results within acceptable ranges.
  • Your protein levels (albumin) in the blood are above a minimum level.
  • Your kidneys are working well enough, based on a kidney function measurement.
  • If you have HIV, you are on effective treatment and your virus levels are undetectable within the past 6 months.
  • If you have chronic hepatitis B, your virus levels are undetectable while on appropriate treatment.
  • If you have had hepatitis C, you have been successfully treated and cured, or are currently on treatment with undetectable virus levels.
  • If you have or have had another type of cancer, it does not interfere with this trial's treatment or assessments (confirm with trial site).
  • If you have a history of heart problems or have been treated with medicines that affect the heart, your heart function must meet a minimum standard as assessed by your doctor.
  • You are able to swallow pills by mouth.
  • If you are a woman who could become pregnant, or a man whose partner could become pregnant, you must agree to use effective birth control during the trial and for 6 months after finishing the study drug.
  • You are willing and able to give written informed consent to participate.

Who may not be able to join:

  • You are still experiencing significant side effects from a previous cancer treatment (other than hair loss).
  • You are currently taking part in another clinical trial for your cancer.
  • Your cancer has spread to distant parts of your body (such as other organs).
  • You have previously received more than one course of radiation therapy to the head and neck area that overlaps with where treatment would be given in this trial.
  • Your tumor surrounds more than half of a major blood vessel in the neck called the carotid artery.
  • Your tumor has grown into the jawbone or has broken through the skin.
  • You have had a serious allergic reaction to a drug similar to the study drug (camonsertib), or to radiation therapy.
  • You have another serious illness or condition that would make it unsafe for you to participate.
  • You are currently pregnant or breastfeeding.
  • You have been diagnosed with scleroderma (a connective tissue disease).
  • You are currently taking certain medications that strongly interact with the study drug — your doctor or the trial team can review your current medicines to check (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
13 February 2027
Est. completion
31 May 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of adverse events (AEs); Maximum tolerated dose (MTD) of camonsertib and concurrent stereotactic body radiation therapy (SBRT) reirradiation; Incidence of late toxicities (dose expansion phase)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov