This study is for patients who have been diagnosed with low grade, intermediate risk non-muscle invasive bladder cancer. It is testing an investigational drug called TYRA-300. "Investigational" means that the drug has not been approved by the United States Food and Drug Administration (FDA).

The purpose of the study is to see whether TYRA-300 can shrink or eliminate bladder tumors without surgery. Normally, standard care involves a surgery called transurethral resection of bladder tumor (TURBT), but in this study at least one tumor will remain in place to see if the study drug works. The study will also evaluate the genetics of the cancer to see if certain mutations or changes in proteins affect how the drug works.

TYRA-300 is taken by mouth once daily. The dose level will be assigned by the study doctor. Participants may be in the study for about 36 months, which includes a screening period (up to 28 days), a study treatment phase (with visits every 4 weeks and more frequent visits during the first 8 weeks), an end-of-treatment visit, a safety follow-up about 28 days later, and long-term follow-up every 12 weeks. There will be a total of 3 patients enrolled locally over the course of 12 months.

The study is for patients that have been diagnosed with carcinoma in situ of the bladder (localized bladder cancer, also called "non-muscle invasive bladder cancer") with or without Ta-T1 papillary disease (Ta means that the cancer is only in the innermost layer of the bladder lining, T1 means that the cancer has started to grow into the connective tissue beneath the bladder lining). The investigational drug used in this study is ONCOFID-P-B. The main purpose of this study is to understand if the study medicine ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy. Participants can expect to be in this study for up to 4 years and will include a screening period of up to 4 weeks followed by up to 33 study visits to the study site.