Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
NCT ID: NCT06995677
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-06-27
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Cohort A (DCA)
TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
TYRA-300 60mg
Self-administered 60mg dose Oral tablet(s) given daily
Dose Cohort B (DCB)
TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
TYRA-300 50mg
Self-administered 50mg dose Oral tablet(s) given daily
Possible Dose Cohort C (DCC)
To Be Determined- TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
TYRA-300 Dose TBD
To Be Determined Dose: Self-administered Oral tablet(s) given daily
Interventions
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TYRA-300 60mg
Self-administered 60mg dose Oral tablet(s) given daily
TYRA-300 50mg
Self-administered 50mg dose Oral tablet(s) given daily
TYRA-300 Dose TBD
To Be Determined Dose: Self-administered Oral tablet(s) given daily
Eligibility Criteria
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Inclusion Criteria
* 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 resectoscope loop to 2 loops, refer to Section 8.1.5) residual visible tumor as a marker lesion(s) left behind:
1. Ta low grade
2. T1 low grade
* Participants must have intermediate risk NMIBC, defined as having any of the following characteristics (AUA Guidelines, 2024)
1. Recurrence within 1 year, LG Ta
2. Solitary LG Ta \>3cm
3. LG Ta, multifocal
4. 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: i.Total bilirubin \< or = ULN ii. Alanine aminotransferase (ALT) \< or = ULN iii. Aspartate aminotransferase (AST) \< or = ULN f. Renal function: i. estimated glomerular filtration rate \>60 mL/min calculated using the modification of diet in renal disease equation or CKD-EPI formula ii. Serum Phosphate level \< or = ULN prior to starting treatment g. Coagulation i. International normalized ratio (INR) \< or = 1.5 x ULN
* 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 to continue contraception for 3 months (males) and 6 months (females) after the last dose of study treatment. Potential male participants should consider the potential impact of TYRA-300 on their ability to father a child and discuss options with the site study staff.
* 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 the compounds in antiretroviral therapy may be on the prohibited medications list. Allowances will be made to ensure the participant's HIV treatment continues uninterrupted following a discussion with the Sponsor's medical monitor. A discussion of the impact of the antiretroviral therapy on TYRA- 300 needs to be discussed with the potential participant prior to C1D1.
* 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
Exclusion Criteria
* 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 dose of TYRA-300
* 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
18 Years
ALL
No
Sponsors
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Tyra Biosciences, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Doug Warner, MD
Role: STUDY_CHAIR
Tyra Biosciences, Inc
Locations
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Tri Valley Urology - Murrieta
Murrieta, California, United States
Genesis Research
San Diego, California, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
The Bronx Veterans Medical Research Foundation, Inc.
The Bronx, New York, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates PC
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Istituti Fisioterapici Ospitalieri (IFO)
Rome, Italy, Italy
Centro Médico Teknon
Barcelona, Spain, Spain
Hospital Clínico San Carlos
Madrid, Spain, Spain
Hospital Universitario 12 de Oc
Madrid, Spain, Spain
Countries
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Central Contacts
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Other Identifiers
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TYR300-202
Identifier Type: -
Identifier Source: org_study_id