TYRA-300-B01 for Non-muscle invasive bladder cancer

Inclusion criteria

• {"criterion_text":"-1. Participants aged 18 or older.\n-2. Participants with histologically confirmed low grade Non-Muscle Invasive Bladder Cancer (NMIBC) within 6 weeks prior to randomization with prior diagnostic biopsy/ Transurethral resection of bladder tumor (TURBT) to confirm stage and grade and with at least 3 mm and not more than 12 mm total residual visible tumor as a marker lesion(s) left behind: a. Ta low grade; b. T1 low grade.\n-3. Participants must have intermediate risk NMIBC, defined as having any of the following characteristics: a. Recurrence within 1 year, LG Ta; b. Solitary LG Ta >3cm; c. LG Ta, multifocal; d. LG T1.\n-4. Documented activating FGFR3 mutation or fusion.\n-5. Have undergone bladder mapping and identification of marker lesion(s) within 6 weeks prior to randomization.\n-6. No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of randomization.\n-7. No prior BCG administration within 1 year of date of consent.\n-8. No intravesical chemotherapy within 8 weeks prior to C1D1.\n-9. Eastern Cooperative Oncology Group (ECOG) 0-1\n-10. Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial\n-11. Adequate bone marrow, liver, and renal function."}

Exclusion criteria

• {"criterion_text":"-1. Presence of tumor in the ureter or prostatic urethra.\n-2. Current or previous history of muscle invasive bladder cancer.\n-3. Current or previous history of lymph node positive and/or metastatic bladder cancer.\n-4. Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder.\n-5. Currently receiving systemic cancer therapy (cytotoxic or immunotherapy).\n-6. Current or prior history of pelvic external beam radiotherapy.\n-7. Current or history of receiving a prior FGFR inhibitor.\n-8. Systemic immunotherapy within 6 months prior to randomization.\n-9. Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will be default to 30 days.\n-10. Prior treatment with an intravesical agent within 8 weeks of C1D1.\n-11. Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination."}

Primary endpoints

• {"endpoint_text":"-Complete response (CR) rate at 3 months","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"-Duration of response (responders only).","definition_or_measurement_approach":""}
• {"endpoint_text":"-Time to recurrence (responders only)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Recurrence-free survival rate at 12 months and 24 months (responders only)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Progression-free survival (all participants)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Cmax, Tmax, AUC0-last, AUCTau, AUC0-infinity, Vd/F, CL/F, and t1/2.","definition_or_measurement_approach":"Pharmacokinetic parameters measured: Cmax, Tmax, AUC0-last, AUCTau, AUC0-infinity, Vd/F, CL/F, and t1/2."}
• {"endpoint_text":"-Incidence and severity of adverse events, incidence of impact on study drug dosing, changes in clinical laboratory parameters, vital sign changes.","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

16-09-2025

Latest Decision Or Authorization Date

08-10-2025

Processing Time Days

22

Number Of Sites

5

Number Of Participants

15

Spain

Earliest CTIS Part Ii Submission Date

06-10-2025

Latest Decision Or Authorization Date

16-10-2025

Processing Time Days

10

Number Of Sites

9

Number Of Participants

24

France

Earliest CTIS Part Ii Submission Date

03-10-2025

Latest Decision Or Authorization Date

15-10-2025

Processing Time Days

12

Number Of Sites

3

Number Of Participants

9

Primary sponsor

Full Name

Tyra Biosciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Fortrea Inc.

Responsibilities

codes 1,13,2,5,6,8

Name

Almac Clinical Services LLC

Responsibilities

Secondary labelling and distribution of IP

Name

Almac Clinical Services (Ireland) Limited

Responsibilities

EU QP release and distribution of IP

Name

Almac Group Limited

Responsibilities

Primary for IP returns and accountability. Back-up for EU QP release, secondary labelling and distribution of IP

Name

Medidata Solutions Inc.

Responsibilities

code 6

Name

Endpoint Clinical Inc.

Responsibilities

code 3

Name

Signant Health LLC

Responsibilities

code 7

Name

Advarra Inc.

Responsibilities

Central IRB

Name

Charles River Laboratories Inc.

Responsibilities

code 4

Name

LabConnect GmbH

Responsibilities

code 4

Third parties

• {"country":"Belgium","full_name":"A.A.C (Administration & Answering Center)","duties_or_roles":"Call center 24h","organisation_type":"Industry"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Secondary labelling and distribution of IP","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"EU QP release and distribution of IP","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code 3","organisation_type":"Industry"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"Primary for IP returns and accountability. Back-up for EU QP release, secondary labelling and distribution of IP","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Central IRB","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"codes 1,13,2,5,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Pharmaspecific","duties_or_roles":"Patient reimbursement","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Welocalize Inc.","duties_or_roles":"Translation services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}