Phase 2 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.

Who might be able to join this trial:

• People who have given written consent and are able to cooperate with the study treatment and follow-up visits
• People aged 18 or older at the time of giving consent
• People with an advanced solid tumour cancer that has been confirmed by laboratory testing of tissue or cell samples, where standard treatments are no longer working, are no longer considered suitable by the treating doctor, or have been declined by the person
• People whose cancer shows measurable or assessable signs of growth or spread that can be tracked during the trial
• People willing to allow the trial team to access and analyse any stored tumour tissue samples, or to provide a fresh tumour sample if no stored tissue is available (requirements vary depending on which part of the trial a person is being considered for — confirm with trial site)
• People in Part B of Phase 1 whose cancer type is one where a specific biological pathway (PGE2/EP4 signalling) is thought to play a significant role — this includes certain colorectal, stomach, head and neck, prostate, pancreatic, lung, bladder, cervical, kidney, and other cancers, including some with specific gene mutations (confirm with trial site)
• People in Phase 2a with one of these specific cancer types: colorectal cancer that is microsatellite stable with certain gene mutations (PIK3CA or HER2, or other agreed mutations), stomach or gastroesophageal junction cancer, clear cell kidney cancer, or advanced prostate cancer that is no longer responding to hormone treatment (mCRPC)
• People in Phase 2a or Part B of Phase 1 who have cancer types where a certain type of immunotherapy (anti-PD-1/PD-L1) is a standard treatment must have already received that treatment and have had their disease progress either during or within 6 months after that treatment
• People with a life expectancy of at least 12 weeks
• People with a good general level of physical functioning, able to carry out everyday activities with minor limitations at most (ECOG performance status 0 or 1 — confirm with trial site)
• People whose blood and body chemistry test results fall within the ranges specified by the trial protocol (confirm with trial site)
• People with stable thyroid function, including those on a stable dose of thyroid replacement medication

Who may not be able to join:

• People who have had radiotherapy (other than for pain relief), chemotherapy, other anti-cancer treatments, or other trial medications within the 4 weeks before joining, or immunotherapy within the 12 weeks before the first dose of the trial treatment (exceptions may apply for lifelong hormone suppression in prostate cancer — confirm with trial site)
• People still experiencing side effects from previous cancer treatments that are more than mild in severity
• People with cancer that has spread to the brain or spinal cord, unless that spread has been treated, is stable on scans, causes no symptoms, and steroid medication was stopped at least 4 weeks before joining
• Women who are able to become pregnant, or who are already pregnant or breastfeeding (some exceptions may apply — confirm with trial site)
• Men whose partners are able to become pregnant (some exceptions may apply — confirm with trial site)
• People who have not yet recovered from major chest or abdominal surgery
• People with serious non-cancer health conditions, including active infections that are not under control
• People with a known history of tuberculosis (active or latent), HIV, or hepatitis B or C
• People who have previously been treated with a type of drug called an EP4 inhibitor
• People who have taken a specific type of anti-inflammatory medication (selective COX-2 inhibitor) within the 8 weeks before joining
• People with a known allergy or intolerance to hydroxypropyl methylcellulose (an ingredient in the trial medication)
• People who have used systemic immune-suppressing medications within the 2 weeks before joining (some exceptions may apply — confirm with trial site)
• People with significant heart or blood vessel disease
• People with a known active stomach ulcer, or who regularly experience stomach pain, indigestion, or acid reflux (one or more episodes per week)
• People currently enrolled in or planning to join another interventional clinical trial at the same time
• People who have difficulty swallowing or absorbing oral medications
• People where the treating doctor considers the trial would not be in that person's best interests for any other reason
• People in Part B of Phase 1 or Phase 2a who have received any live vaccine in the 4 weeks before joining
• People in Part B of Phase 1 or Phase 2a with a diagnosis of immune system deficiency
• People in Part B of Phase 1 or Phase 2a with an active autoimmune disease that required systemic treatment within the past 2 years
• People in Part B of Phase 1 or Phase 2a with a history or suspected diagnosis of interstitial lung disease, a history of lung inflammation (non-infectious) that required steroid treatment, or current lung inflammation
• People in Part B of Phase 1 or Phase 2a with a known allergy to atezolizumab (a drug used in combination in this trial) or any of its ingredients
• People in Part B of Phase 1 or Phase 2a who previously had a serious reaction to cancer immunotherapy that required steroids, other immune-suppressing treatment, or led to stopping that treatment

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