A multicenter, open-label, Phase 2 study of TYRA-300 in non-muscle invasive bladder cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Tyra Biosciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Dec 2025 → ongoing

Decision date (initial)

2025-10-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Tyra Biosciences, Inc

External identifiers

EU CT number

2025-521277-14-00

ClinicalTrials.gov

NCT06995677

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic

To evaluate the efficacy of TYRA-300.

Secondary objectives 3

1. -To further evaluate the efficacy of TYRA-300.
2. -To evaluate the PK profile of TYRA-300.
3. -To evaluate the safety and tolerability of TYRA-300.

Conditions and MedDRA coding

Non-muscle invasive bladder cancer (NMIBC)

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

NA

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 1. Participants aged 18 or older.
2. 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.
3. 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.
4. 4. Documented activating FGFR3 mutation or fusion.
5. 5. Have undergone bladder mapping and identification of marker lesion(s) within 6 weeks prior to randomization.
6. 6. No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of randomization.
7. 7. No prior BCG administration within 1 year of date of consent.
8. 8. No intravesical chemotherapy within 8 weeks prior to C1D1.
9. 9. Eastern Cooperative Oncology Group (ECOG) 0-1
10. 10. Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial
11. 11. Adequate bone marrow, liver, and renal function.

Exclusion criteria 11

1. 1. Presence of tumor in the ureter or prostatic urethra.
2. 2. Current or previous history of muscle invasive bladder cancer.
3. 3. Current or previous history of lymph node positive and/or metastatic bladder cancer.
4. 4. Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder.
5. 5. Currently receiving systemic cancer therapy (cytotoxic or immunotherapy).
6. 6. Current or prior history of pelvic external beam radiotherapy.
7. 7. Current or history of receiving a prior FGFR inhibitor.
8. 8. Systemic immunotherapy within 6 months prior to randomization.
9. 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.
10. 10. Prior treatment with an intravesical agent within 8 weeks of C1D1.
11. 11. Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Complete response (CR) rate at 3 months

Secondary endpoints 6

1. -Duration of response (responders only).
2. -Time to recurrence (responders only)
3. -Recurrence-free survival rate at 12 months and 24 months (responders only)
4. -Progression-free survival (all participants)
5. -Cmax, Tmax, AUC0-last, AUCTau, AUC0-infinity, Vd/F, CL/F, and t1/2.
6. -Incidence and severity of adverse events, incidence of impact on study drug dosing, changes in clinical laboratory parameters, vital sign changes.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Tyra Biosciences Inc.

Sponsor organisation

Tyra Biosciences Inc.

Address

2656 State Street

City

Carlsbad

Postcode

92008-1626

Country

United States

Scientific contact point

Organisation

Tyra Biosciences Inc.

Contact name

Douglas Warner

Public contact point

Organisation

Tyra Biosciences Inc.

Contact name

Fortrea Global Regulatory Submissions

Third parties 14

Locations

3 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications