Phase 1 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Criteria that apply to all parts of the trial (Arms 1a, 1b, 2, and 3):

• People who are 18 years of age or older.
• People who have at least one tumour that can be measured using standard imaging guidelines.
• People whose tumours that were previously treated with radiation or local treatments show clear signs of growth or spread on imaging scans.
• People whose side effects from previous cancer treatments (other than hair loss and nerve-related symptoms) have largely resolved, and whose immune-related side effects from checkpoint inhibitor therapy have fully resolved.
• People whose kidneys are functioning at an adequate level, based on a specific blood test calculation.
• People whose liver function blood test results are within acceptable ranges for the trial.
• People whose blood counts (white blood cells, red blood cells, and platelets) are at adequate levels.
• People with a general health and activity level rated as 0 or 1 on a standard oncology scale, meaning they are fully active or have minor restrictions but are able to carry out light activity (confirm with trial site).
• People whose heart pumping function is measured at 50% or above on a heart imaging scan.
• People who are not surgically sterile or past menopause must be willing to use medically acceptable birth control during treatment and for a defined period after the last dose; male participants must also avoid donating sperm during this time.
• For Arms 1a, 1b, and 2: People who have waited a sufficient period of time after their last cancer treatment before starting the study drug (confirm with trial site for the exact timing requirement).

For Arm 1a only:

• People with a locally advanced or metastatic (Stage IV) solid tumour that has continued to grow or spread during or after standard treatment, and for whom no other suitable treatments are available, as determined by the treating doctor.

For Arms 1b and 2 only:

• People with confirmed advanced or metastatic head and neck squamous cell cancer (a specific type of cancer affecting the head and neck region) that has progressed during or after platinum-based chemotherapy and/or certain immunotherapy drugs targeting specific immune checkpoints.
• People with head and neck squamous cell cancer that has spread or come back in a way that cannot be cured by surgery or radiation.
• For Arm 1b only: People who have a tumour that can be safely biopsied (a small tissue sample taken) before and during treatment, and who are willing to have those biopsies done.

For Arm 3 only:

• People with confirmed locally advanced or metastatic head and neck squamous cell cancer located in the mouth, throat, voice box, or the area connecting the throat to the oesophagus — but not in the nasopharynx (the upper part of the throat behind the nose).
• People who have already received immunotherapy targeting specific immune checkpoint proteins for their cancer, and whose cancer has since continued to grow or spread.
• People with head and neck squamous cell cancer that has spread or come back in a way that cannot be cured by surgery or radiation.
• People who consent to provide HPV status testing results and results from a specific tumour protein test (PD-L1 score).
• People who consent to provide tumour tissue samples as required for enrolment.

Who may not be able to join:

Criteria that apply to all parts of the trial (Arms 1a, 1b, 2, and 3):

• People who have previously received a specific type of treatment targeting a protein called CCR8.
• People who have had a severe (Grade 4) allergic or anaphylactic reaction to any antibody-based therapy or to any ingredient in the study drugs.
• People who have had major surgery within the four weeks before the screening period.
• People with unstable or poorly controlled serious health conditions — such as heart instability, lung conditions including inflammation of the lungs, uncontrolled diabetes, or abnormal lab results — that the treating doctor believes would increase health risks from taking part in the study.

For Arms 1b and 2 only:

• People who have received more than four previous systemic (whole-body) treatment regimens for their advanced or metastatic cancer.
• People whose cancer is nasopharyngeal carcinoma or a nasal cavity cancer type other than head and neck squamous cell cancer (such as adenocarcinoma, neuroendocrine tumours, or mucosal melanoma).
• People who are on ongoing blood-thinning medication that cannot be safely paused for the required biopsies (applies to those who need to provide tumour biopsies).

For Arm 3 only:

• People who have received two or more previous systemic treatment regimens for their advanced or metastatic cancer.

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