Phase 1 Mesothelioma Trial, Recruiting

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

Part A (Early phase – open to various solid tumours)

Who might be able to join this trial:

• People aged 18 or older who are willing and able to provide written consent to participate
• People with advanced, spreading, or worsening solid tumour cancers where no effective standard treatment is available, or where standard treatments are considered unsuitable by the doctor running the trial
• People whose cancer can be measured using standard imaging criteria (known as RECIST 1.1)
• People who are relatively well and able to carry out daily activities, as assessed by a standard health scale (ECOG score of 0 or 1)

Who may not be able to join:

• People whose cancer is known to overproduce a protein called HER2
• People who have received radiotherapy (other than for pain relief), hormone therapy, chemotherapy, or another experimental treatment within the past 28 days (or 42 days for certain specific chemotherapy drugs) — note that bone-protecting medications (bisphosphonates) and hormone-suppressing injections for prostate cancer may be continued
• People still experiencing significant side effects (above a moderate level, called Grade 2) from previous treatments, except for hair loss or nerve-related symptoms
• People who have had treatment directed at brain tumours and show signs that those tumours have grown again within 28 days of that treatment
• People who are pregnant, breastfeeding, or capable of becoming pregnant, unless a blood pregnancy test is negative before joining and at least one highly effective form of contraception is used throughout
• Men whose partners could become pregnant, unless they agree to use barrier contraception (condom plus spermicide)
• People who have had major surgery and have not yet fully recovered

Part B (Later phase – focused on specific cancer types and gene changes)

Who might be able to join this trial:

• People aged 18 or older who are willing and able to provide written consent to participate
• People with advanced, spreading, or worsening solid tumours that have specific genetic changes, including:
  • Non-small cell lung cancer (adenocarcinoma or squamous cell type) with YES1 or TYMS gene amplification, or a FAT1 gene mutation
  • Kidney cancer with an NF2 gene mutation
  • Mesothelioma (a cancer affecting the lining of organs) with an NF2 gene mutation
  • Other solid tumours with a pathogenic mutation in NF2, FAT1, or LATS1 genes, or amplification of TYMS, YAP1, YES1, or TAZ1 genes
  • Bile duct cancer (cholangiocarcinoma) with IDH1 or IDH2 gene mutations
• People who have already received between 1 and 3 prior treatments appropriate for their cancer type and stage
• People whose cancer can be measured using standard imaging criteria (RECIST 1.1, or a modified version for mesothelioma)
• People who are relatively well and able to carry out daily activities, as assessed by a standard health scale (ECOG score of 0 or 1)

Who may not be able to join:

• People with certain combinations of cancer type and gene changes, including:
  • Bowel cancer, brain tumours (glioma), melanoma, or anaplastic thyroid cancer that has a BRAF gene mutation
  • Non-small cell lung cancer with a BRAF or EGFR gene mutation, or HER2 overexpression
  • Breast, stomach, oesophageal junction, or bile duct cancers with HER2 gene changes
• People with anal, penile, cervical, or head and neck cancers who have a prior history of human papillomavirus (HPV) infection
• People who have received radiotherapy (other than for pain relief), hormone therapy, chemotherapy, or another experimental treatment within the past 28 days (or 42 days for certain specific chemotherapy drugs) — note that bone-protecting medications (bisphosphonates) and hormone-suppressing injections for prostate cancer may be continued
• People still experiencing significant side effects (above a moderate level, called Grade 2) from previous treatments, except for hair loss or nerve-related symptoms
• People who are pregnant, breastfeeding, or capable of becoming pregnant, unless a blood pregnancy test is negative before joining and at least one highly effective form of contraception is used throughout
• Men whose partners could become pregnant, unless they agree to use barrier contraception (condom plus spermicide)
• People who have had major surgery and have not yet fully recovered

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