Phase 1 Pancreatic 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:

• People who have a tumour that can be measured, that is accessible for a biopsy, and who are willing to have two biopsies (one before treatment and one during treatment), and can provide stored tumour tissue if it is available.
• People who are generally well enough to carry out daily activities with little or no limitation, as measured by a standard medical scale (ECOG score of 0 or 1).
• People who have at least one tumour that can be measured on a CT or MRI scan taken within 21 days before the screening visit.
• People with skin squamous cell carcinoma (CSCC) (Cohort 1 – single agent) who have already received a type of immunotherapy called anti-PD-1, or who were unable to tolerate it or were not eligible for it, in the advanced or metastatic setting, and who have not previously received anti-EGFR antibody treatment for advanced or metastatic disease.
• People with head and neck squamous cell carcinoma (HNSCC) that has spread or cannot be surgically removed (Cohort 2 – combination treatment), where the tumour scores 1 or higher on a specific protein test (CPS ≥ 1), with the primary tumour located in the oropharynx, oral cavity, hypopharynx, or larynx (not the nasopharynx), who have not had prior systemic therapy for recurrent or metastatic disease (with limited exceptions), and who have not previously received anti-EGFR antibodies (with limited exceptions). Tissue for a specific biomarker test and HPV status results are also required for oropharyngeal cancer.
• People with squamous cell carcinoma of the anal canal (SCAC) that is locally advanced, cannot be surgically removed, or has spread (Cohort 3 – combination treatment), who have received at least one but no more than two prior lines of systemic treatment for advanced disease, and who have not previously received immune checkpoint inhibitor therapy.
• People with stage IV squamous non-small cell lung cancer (SqNSCLC) (Cohort 5 – combination treatment), confirmed by laboratory testing, who have progressed after one prior systemic therapy in the metastatic setting, and who have not previously received anti-EGFR antibody treatment in the metastatic setting. People with mixed tumour types (such as adenosquamous) are not included.
• People with HNSCC that has spread or cannot be surgically removed (Cohort 6 – combination treatment), where the tumour scores below 1 on a specific protein test (CPS < 1), as confirmed by a specific laboratory test.
• People with colorectal cancer (CRC) (Cohort 9 – randomised to single agent or combination), who have received at least two but no more than three prior lines of systemic therapy, including two standard treatment regimens.

Who may not be able to join:

• People who have received anti-EGFR antibody treatment within 4 weeks before the first dose of the study drug (applies to the dose-finding part of the trial).
• People who have previously received any treatment that targets a protein called TGF-beta.
• People who have previously had a significant allergic or intolerance reaction (Grade 2 or higher) to a drug called cetuximab, other anti-EGFR treatments, or similar protein-based medicines, or who had to stop such a treatment due to side effects.
• People who are pregnant or breastfeeding.
• People who need to take corticosteroids (such as prednisone at more than 10 mg per day) or other medicines that suppress the immune system within 14 days before the first dose, unless these are applied to the skin, nose, lungs, or eyes only.
• People who have a history of blood cancer or a different solid tumour (other than the ones being studied), unless they have received potentially curative treatment and have had no signs of that disease for at least 2 years. Some low-risk skin cancers, early-stage prostate cancer, and certain non-invasive cancers are exceptions. People enrolling in the CSCC cohort may have a type of blood cancer called chronic lymphocytic leukaemia, as long as they are not actively being treated for it.
• People living with HIV who have a CD4+ cell count below 250 cells/uL, or who have not been on stable HIV treatment for at least four weeks, or who have an HIV viral load above 400 copies/mL before joining the trial.
• People with a chronic hepatitis B infection that is active and meets the standard criteria for treatment, who are not already on a medicine to suppress the virus before starting the study.
• People with a known history of hepatitis C who have not completed a full course of curative antiviral treatment, or who still have a detectable level of hepatitis C virus in their blood.

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