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Clinical Trials in Spain / NCT06995677
Recruiting Phase 2

Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

NCT06995677 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2025-06-27
Last updated
2026-09-29

Condition(s) studied

Low-grade NMIBCFGFR Gene AmplificationFGFR Gene AlterationsFGFR3 Gene AlterationFGFR3 Gene MutationFGFR3 Gene Fusions

Investigational drug(s) / intervention(s)

TYRA-300 60mg →TYRA-300 50mg →TYRA-300 Dose 70 mg →

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 70 mg: Self-administered 70 mg Oral tablet(s) given daily

Study summary

Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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 * Participants with histologically confirmed low-grade NMIBC within 8 weeks prior to C1D1 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 8.1.6) residual visible tumor as a marker lesion(s) left behind: 1. Ta low grade 2. T1 low grade * Participants must have protocol-defined intermediate risk NMIBC and meet at least one of the following criteria 1. Recurrence within 1 year, LG Ta 2. Solitary LG Ta \>3cm 3. LG Ta, multifocal 4. 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. Liver function: i. Total bilirubin \< or = ULN ii. Alanine aminotransferase (ALT) \< or = ULN iii. Aspartate aminotransferase (AST) \< or = ULN c. Renal function: i. estimated glomerular filtration rate \>30 mL/min calculated using the modification of diet in renal disease equation or CKD-EPI formula j. Serum Phosphate level \< or = ULN d. 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 must refrain from donating sperm until 3 months 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. * 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 active hepatitis B virus (HBV) infection should be on a suppressive antiviral therapy prior to C1D1. Note: participants with no history of chronic HBC infection do not need serology testing at Screening. * 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. Note: participants with no history of chronic HCV infection do not need serology testing at Screening. 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 * 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 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 during Screening as well as any active ocular abnormality at baseline (during Screening) that may increase the chance of ocular toxicity. * 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, and others in consultation with the Sponsor). * 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

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
Urology Centers of Alabama Homewood Alabama Recruiting
Arkansas Urology Little Rock Arkansas Recruiting
Tri Valley Urology - Murrieta Murrieta California Recruiting
Eisenhower Medical Associates Rancho Mirage California Recruiting
Om Research LLC San Diego California Recruiting
Associated Urological Specialists Chicago Ridge Illinois Recruiting
Duly Health and Care Lisle Illinois Recruiting
Urology of Indiana Greenwood Indiana Recruiting
First Urology Jeffersonville Indiana Recruiting
University of Kansas Medical Center (KUMC) Kansas City Kansas Recruiting
Johns Hopkins University Baltimore Maryland Recruiting
Greater Boston Urology Plymouth Massachusetts Recruiting
Specialty Clinical Research of St. Louis St Louis Missouri Recruiting
Atlantic Health System Morristown New Jersey Recruiting
New Jersey Urology, LLC (Summit Health - Washington Township) Voorhees Township New Jersey Recruiting
Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Queens - Infusion Center Astoria New York Recruiting
NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers New York New York Recruiting
Associated Medical Professionals of NY Syracuse New York Recruiting
State University of New York (SUNY) Upstate Medical University Syracuse New York Recruiting
The Bronx Veterans Medical Research Foundation, Inc. The Bronx New York Recruiting
Duke Cancer Institute Durham North Carolina Recruiting
Associate Urologist of North Carolina Raleigh North Carolina Recruiting
The James at Brain and Spine Hospital (OSU) Columbus Ohio Recruiting
Oregon Urology Institute Springfield Ohio Recruiting
MidLantic Urology Bala-Cynwyd Pennsylvania Recruiting
Keystone Urology Specialists Lancaster Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Carolina Urologic Research Center Myrtle Beach South Carolina Recruiting
Lowcounty Urology Clinics, P.A. North Charleston South Carolina Recruiting
Conrad Pearson-Memphis Germantown Tennessee Recruiting
Urology Associates PC Nashville Tennessee Recruiting
Urology Austin Austin Texas Recruiting
Urology Clinics of North Texas Dallas Texas Recruiting
Baylor College of Medicine Houston Texas Recruiting
Urology San Antonio San Antonio Texas Recruiting
Epworth Freemasons-Victoria Parade Richmond Victoria Recruiting
Istituti Fisioterapici Ospitalieri (IFO) Rome Italy Recruiting
Istituto Europeo di Oncologia Milan Italy Recruiting
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara Pisa Italy Recruiting

+ 8 more sites — see the full list on the official registry below.

More Tyra Biosciences, Inc trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06995677 on ClinicalTrials.gov ↗ ← All trials in Spain