TYRA-300 for Bladder Cancer

(SURF302 Trial)

Recruiting at 3 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new treatment, TYRA-300, for individuals with a specific type of bladder cancer. It targets patients with low-grade, intermediate-risk non-muscle invasive bladder cancer involving changes in the FGFR3 gene. The trial will test various doses of TYRA-300 to assess its effectiveness and safety. Suitable candidates have recurrent bladder cancer or tumors larger than 3 cm, with a confirmed FGFR3 change. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that some medications might be prohibited. It's best to discuss your current medications with the study staff to see if any adjustments are needed.

Is there any evidence suggesting that TYRA-300 is likely to be safe for humans?

Research has shown that TYRA-300 was safe and well-tolerated in earlier studies. Patients taking TYRA-300 experienced fewer serious side effects compared to traditional treatments, suggesting it might be gentler on the body.

TYRA-300 is now in a Phase 2 trial, indicating it has already passed initial safety tests. This phase evaluates the treatment's safety in a larger group of people. For those considering joining this trial, the current data presents a positive view of the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TYRA-300 for bladder cancer because it targets FGFR3 alterations, which are common in low-grade, intermediate-risk non-muscle invasive bladder cancer. Unlike traditional treatments like BCG therapy, which involves introducing a live bacterium into the bladder, TYRA-300 is a targeted therapy, potentially offering a more precise approach with fewer side effects. This specificity could lead to better outcomes for patients who have these particular genetic alterations, making it a promising new option in the fight against bladder cancer.

What evidence suggests that TYRA-300 might be an effective treatment for bladder cancer?

Studies have shown that TYRA-300, an oral pill, is a promising treatment for bladder cancer, particularly in patients with changes in the FGFR3 protein. This protein can promote cancer cell growth, and TYRA-300 blocks it. Early results suggest that TYRA-300 effectively reduces or slows cancer growth. It also seems safer, with fewer serious side effects than traditional treatments. This trial will test TYRA-300 in different dose cohorts to evaluate its effectiveness and safety. Research suggests that targeting FGFR3 could transform bladder cancer treatment, offering new hope for patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Doug Warner, MD

Principal Investigator

Tyra Biosciences, Inc

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06995677

NCT06995677 | Efficacy and Safety of TYRA-300 in ... A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk ...

2. ir.tyra.bio ir.tyra.bio/news-releases/news-release-details/tyra-biosciences-doses-first-patient-phase-2-study-tyra-300-low

Tyra Biosciences Doses First Patient in Phase 2 Study of ... SURF302 (NCT06995677) is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered ...

3. urotoday.com urotoday.com/index.php?option=com_content&view=article&id=163850:tyra-biosciences-doses-first-patient-in-phase-2-study-of-tyra-300-in-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer-surf302&catid=1160&utm_source=newsletter_14701&utm_medium=email&utm_campaign=uroalerts-oncology-daily&acm=_14701

Tyra Biosciences Doses First Patient in Phase 2 Study of ... SURF302 (NCT06995677) is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered ...

4. targetedonc.com targetedonc.com/view/tyra-300-begins-phase-2-trial-in-fgfr3-altered-nmibc

TYRA-300 Begins Phase 2 Trial in FGFR3-Altered NMIBC A groundbreaking trial for TYRA-300, an oral FGFR3 inhibitor, aims to transform treatment for patients with low-grade intermediate-risk bladder cancer.

5. urologytimes.com urologytimes.com/view/selective-fgfr3-inhibition-represents-promising-novel-approach-in-bladder-cancer

Selective FGFR3 inhibition represents a promising new ... That data showed very good efficacy and tolerability with a much lower likelihood of high-grade adverse events compared with the conventional ...