TYRA-300 for Bladder Cancer

(SURF302 Trial)

Overseen By Grace Indyk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tyra Biosciences, Inc

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Muscle invasive cancer, Metastatic cancer, Uncontrolled cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Doug Warner, MD

Principal Investigator

Tyra Biosciences, Inc

Eligibility Criteria

This trial is for adults over 18 with low grade, intermediate risk non-muscle invasive bladder cancer (NMIBC) that has specific FGFR3 genetic changes. Participants should have had a recurrence within a year or meet other criteria outlined in the AUA Guidelines. They must understand and consent to study procedures but can't join if they don't meet these conditions.

Inclusion Criteria

I am fully active or can carry out light work.

Participants of child-bearing potential must practice effective contraception while on treatment and for specified durations after the last dose

Able to understand and give written informed consent

Exclusion Criteria

Any reason that would substantially impair the ability to comply with study procedures and/or risk to the participant

I have a history of prolonged QT syndrome or my heart's QT interval is over 470 ms.

My cancer is located in the ureter or prostatic urethra.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TYRA-300 monotherapy for FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

• TYRA-300

Trial Overview The trial is testing three different doses of TYRA-300 (60mg, 50mg, and one dose yet to be determined) to see how effective and safe it is for treating bladder cancer patients with alterations in the FGFR3 gene.

Participant Groups

Group I: Possible Dose Cohort C (DCC) Experimental Treatment 1 Intervention

To Be Determined- TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

Group II: Dose Cohort B (DCB) Experimental Treatment 1 Intervention

TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

Group III: Dose Cohort A (DCA) Experimental Treatment 1 Intervention

TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

Who Is Running the Clinical Trial?

Tyra Biosciences, Inc

Lead Sponsor

Trials

4

Recruited

500+