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Tests treatment safety and results for Low-grade NMIBC
Official title Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06995677
What this study is testing
What is TYRA-300 60mg?
TYRA-300 60mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for low-grade nmibc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures
- Able to understand and given written informed consent
- Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with prior diagnostic biopsy/TURBT to confirm stage...
- Ta low grade
- T1 low grade
You likely can't join if
- Presence of tumor in ureter or prostatic urethra:
- Current or previous history of muscle invasive bladder cancer
- Current or previous history of lymph node positive and/or metastatic bladder cancer
- Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder
- Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)
- Currently receiving treatment with a prohibited therapy (refer to Section 6.7.1)
See the full eligibility criteria
- Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures
- Able to understand and given written informed consent
- Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with prior diagnostic biopsy/TURBT to confirm stage and grade and with at least 3 mm and no more than 12 mm total (1/2 a...
- Ta low grade
- T1 low grade
- Participants must have intermediate risk NMIBC, defined as having any of the following characteristics (AUA Guidelines, 2024)
- Recurrence within 1 year, LG Ta
- Solitary LG Ta \>3cm
- LG Ta, multifocal
- LG T1
- Documented activating FGFR3 mutation or fusion (Appendix 4)
- Have undergone bladder mapping and identification of visible marker lesion(s) within 6 weeks prior to randomization (refer to Inclusion Criterion #3)
- No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of randomization
- No prior BCG administration within 1 year of date of consent.
- No intravesical chemotherapy within 8 weeks prior to C1D1.
- ECOG 0-1
- Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial
- Adequate bone marrow, liver, and renal function: b. Bone marrow function: i. Absolute neutrophil count (ANC) \> or = 1,500/mm3 ii. Platelet count \> or = 75,000/mm3 iii. /hemoglobin \> or = 10.0 g/dL e. Liver function...
- Ability to swallow tablets
- Participants (male and female) of child-bearing potential (including females who are post-menopausal for less than 1 year) must be willing to practice effective contraception while on treatment and be willing and able...
- Potential participants who are positive for human immunodeficiency virus (HIV) must have a viral load below the limits of detection and on stable antiretroviral therapy for at least 3 months prior to C1D1. NOTE: some of...
- Potential participants with chronic hepatitis B virus (HBV) infection with active disease should be on a suppressive antiviral therapy prior to C1D1.
- Potential participants patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and must have a HCV viral load below the limit of quantification.
- Potential participants with a history of HCV infection and on current treatment must have a HCV viral load below the limit of quantification
- Presence of tumor in ureter or prostatic urethra:
- Current or previous history of muscle invasive bladder cancer
- Current or previous history of lymph node positive and/or metastatic bladder cancer
- Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder
- Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)
- Currently receiving treatment with a prohibited therapy (refer to Section 6.7.1)
- Current or prior history of pelvic external beam radiotherapy
- Current or history of receiving a prior FGFR inhibitor
- Systemic immunotherapy within 6 months prior to randomization
- Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will default to the 30 days.
- Prior treatment with an intravesical agent within 8 weeks prior to C1D1
- Current ongoing toxicity from previous therapy
- Had major surgery within 4 weeks prior to C1D1
- Any reason that in the view of the investigator, would substantially impair the ability of the participant to comply with study procedures and/or risk to the participant (i.e., uncontrolled diabetes)
- Females who are pregnant, breastfeeding or planning to become pregnant within 6 months after the last dose of TYRA-300 and males who plan to father a child while enrolled in this study or within 3 months after the last...
- Has impaired wound healing capacity
- Serum phosphate levels above the upper limit of normal during screening
- Any ocular condition likely to increase the risk of eye toxicity
- Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
- History of or current uncontrolled cardiovascular disease
- Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300
- Known history of HIV infection, or active hepatitis B or C
- History of a second primary malignancy within 3 years of signing ICF, except for nonmelanoma skin cancer and cured and active surveillance malignancies (i.e., prostate, breast) .
- Known allergy to TYRA-300 or any excipients of the formulated product
- Participants taking strong inhibitors and/or inducers of CYP3A4 enzyme
- History of prolonged QT syndrome or baseline heart rate-corrected QT interval using Fridericia formula (QTcF) interval \>470 ms
The study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Little Rock, Arkansas, United States
- Murrieta, California, United States
- Rancho Mirage, California, United States
- San Diego, California, United States
- Chicago Ridge, Illinois, United States
- Lisle, Illinois, United States
- Greenwood, Indiana, United States
- Jeffersonville, Indiana, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Plymouth, Massachusetts, United States
- St Louis, Missouri, United States
- Morristown, New Jersey, United States
- Voorhees Township, New Jersey, United States
- New York, New York, United States
- Syracuse, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Raleigh, North Carolina, United States
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homewood, Alabama, United States; Little Rock, Arkansas, United States; Murrieta, California, United States; Rancho Mirage, California, United States; San Diego, California, United States; Chicago Ridge, Illinois, United States and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.