Study on the Effectiveness and Safety of TYRA-300 for Patients with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Sponsor: Tyra Biosciences, Inc
ClinicalTrials ID:NCT06995677
This clinical trial is testing a new drug, TYRA-300, to see if it is safe and effective for treating patients with a specific type of bladder cancer that has not spread to the muscle. The study focuses on patients with FGFR3 genetic changes in their cancer.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well the drug TYRA-300 works and how safe it is for patients with a type of bladder cancer called low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) that has changes in the FGFR3 gene. This study is open to adults who meet specific health criteria and have this type of cancer.
Description
This study is a Phase 2 trial conducted at multiple centers, where participants will receive the drug TYRA-300 to see if it can effectively treat their bladder cancer. The study is open-label, meaning both the researchers and participants know what treatment is being given. The main goals are to assess the drug's effectiveness in shrinking tumors and to monitor any side effects. Participants will need to meet certain health criteria and agree to follow the study procedures, including regular check-ups and tests to monitor their health and the cancer's response to the treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and over who can understand and agree to the study requirements.
- Diagnosed with low-grade non-muscle invasive bladder cancer within the last 6 weeks, confirmed by a biopsy.
- Have a small visible tumor left after initial treatment, measuring between 3 mm and 12 mm.
- Have intermediate-risk bladder cancer, which includes certain characteristics like recurrence within a year or multiple small tumors.
- Have a specific genetic change in the FGFR3 gene.
- No cancer in the upper urinary tract or prostate within the last 6 months.
- No BCG treatment within the last year or chemotherapy in the bladder within the last 8 weeks.
- Good overall health with specific blood and organ function levels.
- Able to swallow tablets.
- Agree to use effective birth control during and after the study.
- If HIV positive, must have a stable viral load and be on treatment.
- If have hepatitis B or C, must be on treatment or have a controlled viral load.
Exclusion Criteria
- Cancer in the ureter or prostate.
- History of muscle-invasive bladder cancer or cancer that has spread to lymph nodes or other parts of the body.
- Other types of bladder cancer like squamous cell or adenocarcinoma.
- Currently receiving other cancer treatments or have had certain treatments recently.
- History of pelvic radiation or treatment with FGFR inhibitors.
- Recent major surgery or ongoing side effects from previous treatments.
- Pregnant or breastfeeding women, or those planning to become pregnant soon.
- Men planning to father a child during or shortly after the study.
- Certain health conditions like uncontrolled diabetes or heart disease.
- High phosphate levels or eye conditions that could be worsened by the treatment.
- Taking medications that interact with TYRA-300 or have a history of heart rhythm issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Tri Valley Urology - Murrieta | 92562 | Murrieta | California |
| Genesis Research | 92123 | San Diego | California |
| Carolina Urologic Research Center | 29572 | Myrtle Beach | South Carolina |
| Urology Associates PC | 37209 | Nashville | Tennessee |
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