Phase 1 Liver 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:

All participants (all parts of the trial):

• Adults aged 18 or older
• People whose cancer has not significantly reduced their ability to carry out daily activities (as measured by a standard medical scale called ECOG, with a score of 0 or 1)
• People whose liver, kidneys, and other organs are functioning at an adequate level
• People who are able to swallow tablets or capsules
• People who are able to understand and willing to sign a consent form

Part A only:

• People with a biopsy-confirmed diagnosis of either: locally advanced or inoperable/spread liver cancer (HCC), or an advanced solid tumour that has a specific change in the FGF or FGFR genetic pathway
• People with locally advanced or metastatic HCC who are at a specific stage of disease (BCLC stage B not suitable for local treatment, or stage C), and whose liver is still functioning reasonably well (Child-Pugh class A)
• People who have already received standard treatments appropriate for their cancer type (any number of previous treatments is allowed, including previous FGFR-targeting drugs)
• People who can provide a stored tumour tissue sample from within the past 2 years, if one is available (a new biopsy is not required if no stored sample exists)

Part B, Cohort 1 (liver cancer group):

• People with biopsy-confirmed locally advanced or metastatic HCC who have already received standard treatment
• People at BCLC stage B (not suitable for local treatment) or stage C, with reasonably well-functioning liver (Child-Pugh class A)
• People who have a stored tumour tissue sample (a specific type called FFPE) collected within the past 2 years, available for testing at a central laboratory
• People who have at least one tumour that can be measured on a scan using standard criteria (RECIST v1.1)

Part B, Cohort 2 (specific solid tumours group):

• People with biopsy-confirmed advanced solid tumours (excluding certain bladder cancers with FGFR3 changes, brain tumours, and liver cancer/HCC) who have already received standard treatment
• People whose tumour has a confirmed specific genetic change in the FGFR3 or FGFR4 gene, or extra copies of the FGF19 gene
• People who have at least one tumour that can be measured on a scan using standard criteria (RECIST v1.1)
• People who can provide a stored tumour tissue sample from within the past 2 years, if one is available (a new biopsy is not required if no stored sample exists)

Who may not be able to join:

All participants (all parts of the trial):

• People whose cancer could potentially be treated with local therapies aimed at curing the disease
• People who have not yet recovered from side effects of previous cancer treatments (unless the side effects are permanent or minor, such as hair loss, tiredness, skin colour changes, or mild nerve-related symptoms)
• People who have received certain recent cancer treatments — specifically: immune therapies or antibody treatments within the past 28 days; certain targeted cancer drugs (TKIs) within 5 days or longer depending on how the drug is processed by the body; or other systemic cancer treatments within the past 14 days
• People who had to stop a previous FGFR-targeting treatment because of serious side effects — specifically, severe liver toxicity (Grade 3 or higher) or any Grade 4 side effect
• People with a phosphorus level in the blood that is above the normal range during screening and cannot be brought back to normal with medical management
• People with a history of or currently uncontrolled heart or blood vessel disease
• People with brain metastases (cancer that has spread to the brain) that are active, causing symptoms, or have not been treated
• People with a cancer that started in the brain or central nervous system
• People with digestive system conditions that would interfere with swallowing or absorbing the study drug
• People who are pregnant, breastfeeding, or planning to become pregnant during the study; and men who are planning to father a child while participating
• People whom the trial doctor believes would face significant risks or be unable to follow the study procedures for any reason

Part B, Cohort 1 only:

• People with specific rare subtypes of liver cancer (fibrolamellar HCC, sarcomatoid HCC, or a mixed type involving bile duct cancer)
• People who have previously been treated with FGFR-targeting drugs (either broad FGFR inhibitors or FGFR4-specific inhibitors)

Part B, Cohort 2 only:

• People with locally advanced or metastatic liver cancer (HCC)
• People with bladder cancer (urothelial carcinoma)

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