Low-grade NMIBC study: TYRA-300 vs TYRA-300 Dose
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?
an investigational oral tablet being studied as a potential treatment for low‑grade, intermediate‑risk non‑muscle invasive bladder cancer with FGFR3 alterations
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
- The study aims to see if TYRA-300 is safe and works for patients whose low-grade, intermediate-risk bladder cancer has FGFR3 alterations.
- Who it's for
- Adults with low-grade, intermediate-risk non-muscle invasive bladder cancer that shows FGFR3 gene changes.
- What's involved
- Participants will receive TYRA-300 and have regular check-ups and tests to monitor safety and effect.
- 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 at time of informed consent and willing and able to comply with all required study procedures
- Able to understand and given written informed consent
- Ta low grade
- T1 low grade
- Recurrence within 1 year, LG Ta
You likely can't join if
- 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
- Current or prior history of pelvic external beam radiotherapy for bladder cancer
See the full eligibility criteria
- Participants age ≥18 at time of informed consent and willing and able to comply with all required study procedures
- Able to understand and given written informed consent
- Ta low grade
- T1 low grade
- Recurrence within 1 year, LG Ta
- Solitary LG Ta \>3cm
- LG Ta, multifocal
- LG T1
- Documented negative voiding urine cytology within 2 weeks of C1D1
- Documented activating FGFR3 alteration (mutation or fusion)
- Have undergone bladder mapping and identification of visible marker lesion(s) within 8 weeks prior to C1D1 (refer to Inclusion Criterion #8)
- No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of C1D1.
- No prior BCG administration within 3 months of the date of most recent consent.
- No intravesical chemotherapy within 8 weeks prior to C1D1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 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 as defined as: a. 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 b.
- 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...
- 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.
- Potential participants with active hepatitis B virus (HBV) infection should be on a suppressive antiviral therapy prior to C1D1.
- Participants with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment or be on stable treatment and must have a HCV viral load below the limit of quantification.
- 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
- Current or prior history of pelvic external beam radiotherapy for bladder cancer
- Current or history of receiving a prior FGFR inhibitor
- Systemic immunotherapy for treatment of cancer within 6 months prior to C1D1
- Treatment with an investigational agent within 30 days or 5 half-lives from C1D1, 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 a previous bladder cancer therapy or any toxicity that would impact the interpretability of study results per the Investigator's discretion.
- 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 during Screening as well as any active ocular abnormality at baseline (during...
- History of or current uncontrolled cardiovascular disease
- Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300
- Other malignancy within 3 years of signing ICF, except for skin cancer (e.g. basal cell, squamous cell, melanoma in situ with negative margins) and cured and/or active surveillance malignancies (i.e., prostate, breast...
- Known allergy to TYRA-300 or any excipients of the formulated product
- Participants taking moderate and strong inhibitors and/or inducers of CYP3A4 enzyme and inhibitors of P-gp and BCRP.
- 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 is enrolling
- 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
- Astoria, New York, United States
- New York, New York, United States
- Syracuse, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
+ 24 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, but 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?
This study is enrolling now at 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 38 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.