Phase 2 Bladder 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:

• Adults aged 18 and over who are willing and able to follow all study procedures
• People who can understand the study information and provide written consent
• People with a confirmed diagnosis of low-grade, non-muscle-invasive bladder cancer (a type of bladder cancer that has not grown into the muscle wall), confirmed by biopsy or surgical procedure within the past 6 weeks, with a small amount of visible tumour (of a specific size range) deliberately left in the bladder as a marker
• People whose bladder cancer falls into the "intermediate risk" category, meaning it meets at least one of these conditions: the cancer has come back within 1 year (low grade, Ta stage); a single tumour larger than 3cm (low grade, Ta stage); multiple tumours present (low grade, Ta stage); or low-grade T1 stage cancer
• People whose cancer has a specific genetic change (an activating FGFR3 mutation or fusion) confirmed by testing
• People who have had a bladder mapping procedure to identify the marker tumour(s) within the past 6 weeks
• People with no signs of urothelial cancer in the upper urinary tract or the prostate area, confirmed by imaging within the past 6 months
• People who have not received the bladder treatment BCG within the past year before signing consent
• People who have not had bladder chemotherapy treatment in the 8 weeks before starting the study
• People with a good general performance status (able to carry out daily activities with no or minimal limitations)
• People whose cancer is primarily a specific cell type (urothelial carcinoma), making up at least 80% of the tumour sample
• People with adequate bone marrow, liver, and kidney function, based on specific blood test results falling within acceptable ranges (confirm with trial site)
• People who are able to swallow tablets
• People of childbearing potential (including women who have been through menopause for less than one year) who are willing to use effective contraception during treatment and for 6 months after the last dose (for women) or 3 months after the last dose (for men)
• People living with HIV, provided their viral load is undetectable and they have been on stable HIV treatment for at least 3 months before starting the study (certain HIV medications may need to be reviewed — this would be discussed with the study team)
• People with chronic hepatitis B infection who are already on antiviral treatment to suppress the virus before starting the study
• People with a history of hepatitis C who have completed curative treatment and whose hepatitis C viral load is below the detectable limit
• People currently being treated for hepatitis C, provided their hepatitis C viral load is below the detectable limit

Who may not be able to join:

• People who have tumour present in the ureter or the prostate area
• People with a current or previous history of bladder cancer that has grown into the muscle wall
• People with a current or previous history of bladder cancer that has spread to the lymph nodes or other parts of the body
• People whose bladder cancer is entirely a specific cell type other than urothelial (such as pure squamous cell, pure adenocarcinoma, or pure undifferentiated carcinoma)
• People currently receiving systemic cancer treatment such as chemotherapy, immunotherapy, or targeted therapy
• People currently taking medications that are prohibited under the study guidelines (confirm with trial site)
• People with a current or past history of external beam radiation therapy to the pelvic area
• People who have previously received a treatment that targets the FGFR pathway (an FGFR inhibitor)
• People who have received systemic immunotherapy within the 6 months before joining the study
• People who have taken part in another clinical trial or received an experimental treatment within 30 days (or within 5 half-lives of that treatment, whichever is shorter) before joining
• People who have received any bladder-instilled treatment within 8 weeks before starting the study
• People who still have ongoing side effects from a previous cancer treatment
• People who have had major surgery within 4 weeks before starting the study
• People with any condition that, in the treating doctor's opinion, would make it difficult to safely follow the study procedures (for example, uncontrolled diabetes)
• Women who are pregnant, breastfeeding, or planning to become pregnant within 6 months after the last dose of the study drug; and men who plan to father a child while in the study or within 3 months after the last dose
• People with impaired wound healing
• People whose blood phosphate levels are above the normal range at the screening stage
• People with certain pre-existing eye conditions that may increase the risk of eye-related side effects
• People with a current eye condition involving fluid build-up at the back of the eye (central serous retinopathy or retinal pigmented epithelial detachment)
• People with a current or past history of uncontrolled heart or cardiovascular disease
• People with digestive or gastrointestinal conditions that would affect the ability to take or absorb tablets
• People with a known history of HIV infection, or active hepatitis B or C (note the specific conditions under which HIV and hepatitis B/C may be permitted are listed in the inclusion criteria above — confirm with trial site)
• People who have had another type of cancer diagnosed within the past 3 years, with exceptions for certain skin cancers and some cancers under active surveillance (confirm with trial site)
• People with a known allergy to the study drug (TYRA-300) or any of its ingredients
• People taking certain medications that strongly affect how the liver processes drugs (strong CYP3A4 inhibitors or inducers)
• People with a history of a heart rhythm condition called prolonged QT syndrome, or whose heart electrical measurements at baseline are above a specific threshold (confirm with trial site)

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