Dabogratinib for Bladder Cancer

(SURF303 Trial)

Overseen By Grace Indyk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tyra Biosciences, Inc

Must not be taking: CYP3A inhibitors, CYP3A inducers

Disqualifiers: High grade UTUC, Carcinoma in situ, Muscle invasive bladder cancer, 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: 6 months

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Dabogratinib, to determine its effectiveness in treating low-grade upper tract urothelial carcinoma, a type of bladder cancer. The study divides participants into groups, each receiving different doses to identify the most effective and safe amount. Suitable candidates have confirmed low-risk bladder cancer, have not recently undergone certain cancer treatments, and can provide tissue samples for testing. Those with this type of bladder cancer who meet the criteria are encouraged to consider joining to help discover new treatment options. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that Dabogratinib is likely to be safe for humans?

Research has shown that Dabogratinib, also known as TYRA-300, is generally well-tolerated. Early findings suggest that this treatment has few serious side effects related to specific genetic targets called FGFR2 and FGFR1, which are involved in some cancers. One study found that TYRA-300 was safe and showed early signs of stopping tumor growth in patients with a type of bladder cancer involving FGFR3 changes.

Overall, the safety data so far appears promising, but like any treatment, risks may still exist. Discuss with your doctor whether joining a trial for Dabogratinib is right for you. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Dabogratinib is unique because it represents a new targeted therapy for bladder cancer. Unlike traditional treatments such as chemotherapy or immunotherapy, Dabogratinib targets specific pathways involved in cancer cell growth and survival, potentially leading to more effective results with fewer side effects. Researchers are excited about this treatment as it could offer a more personalized approach to tackling bladder cancer, improving outcomes for patients who may not respond well to existing therapies.

What evidence suggests that Dabogratinib could be an effective treatment for bladder cancer?

Research has shown that Dabogratinib, also known as TYRA-300, may help treat bladder cancer, particularly in patients with changes in a protein called FGFR3. Early results suggest this drug can slow tumor growth by disrupting cancer cell signals. In studies, patients with FGFR3-altered bladder cancer experienced better outcomes, with some showing a reduction in their cancer. Additionally, the treatment has been well-tolerated, causing fewer side effects. Overall, these findings offer hope that Dabogratinib could be effective for people with this specific type of bladder cancer. Participants in this trial will receive Dabogratinib in different dose cohorts to evaluate its effectiveness and safety. ^{1 2 4 6 7}

Who Is on the Research Team?

Erik T. Goluboff, MD, MBA

Principal Investigator

Tyra Biosciences, Inc

Are You a Good Fit for This Trial?

Adults diagnosed with low-grade upper tract urothelial carcinoma (LG UTUC) who have a lesion of at least 5mm, no recent BCG therapy or chemotherapy, and an ECOG performance status of 0-2. Participants must provide tissue for genomic testing and comply with study procedures.

Inclusion Criteria

My cancer was marked for tracking less than 8 weeks ago.

I have a visible tumor that is at least 5mm.

I am 18 or older and can follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dabogratinib (TYRA-300) monotherapy in different dose cohorts

6 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

• Dabogratinib

Trial Overview

The trial is evaluating the effectiveness and safety of Dabogratinib (TYRA-300) in treating LG UTUC. Patients will receive different doses to determine which is most effective: TBD dose, 60mg, or 80mg.

How Is the Trial Designed?

Group I: Study Drug Dose Cohort B (DCB) 80mg Experimental Treatment 1 Intervention

Dabogratinib (TYRA-300) monotherapy in Participants

Group II: Study Drug Dose Cohort A (DCA) 60mg Experimental Treatment 1 Intervention

Dabogratinib (TYRA-300) monotherapy in Participants

Group III: Possible Study Drug Dose Cohort C (DCC) TBD mg Experimental Treatment 1 Intervention

Dabogratinib (TYRA-300) monotherapy in Participants

Who Is Running the Clinical Trial?

Tyra Biosciences, Inc

Lead Sponsor

Trials

4

Recruited

500+

Citations

1.

urotoday.com

urotoday.com/recent-abstracts/urologic-oncology/bladder-cancer/163913-dabogratinib-tyra-300-an-fgfr3-isoform-selective-inhibitor-preclinical-and-initial-clinical-evidence-of-anti-tumor-activity.html?page=1

Dabogratinib (TYRA-300), an FGFR3 isoform-selective ...

Dabogratinib elicited a dose-dependent reduction in downstream signaling across three bladder cancer cell lines harboring an FGFR3 fusion, ...

2.

ir.tyra.bio

ir.tyra.bio/news-releases/news-release-details/tyra-biosciences-reports-interim-clinical-proof-concept-data

Tyra Biosciences Reports Interim Clinical Proof-of-Concept ...

These early data provide support that TYRA-300 can deliver improved anti-tumor activity and tolerability for our FGFR3 altered urothelial cancer ...

3.

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 ...

4.

bcan.org

bcan.org/clinicaltrials/efficacy-and-safety-of-tyra-300-in-participants-with-fgfr3-altered-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer/

Efficacy and Safety of TYRA-300 in Participants With ...

PRIMARY OUTCOMES. Primary Outcome 1 - Measure: To assess the efficacy of TYRA-300 in LG IR-NMIBC participants. Primary Outcome 1 - Timeframe: at 3 months ...

5.

urologytimes.com

urologytimes.com/view/tyra-300-shows-encouraging-safety-efficacy-in-fgfr3-metastatic-urothelial-carcinoma

TYRA-300 shows encouraging safety, efficacy in FGFR3+ ...

TYRA-300 demonstrated promising efficacy in mUC patients, with a 54.5% partial response rate at doses of 90 mg or higher. · The disease control ...

6.

urotoday.com

urotoday.com/recent-abstracts/urologic-oncology/bladder-cancer/163913-dabogratinib-tyra-300-an-fgfr3-isoform-selective-inhibitor-preclinical-and-initial-clinical-evidence-of-anti-tumor-activity.html

Dabogratinib (TYRA-300), an FGFR3 isoform-selective ...

The HIVEC-II study is a multi-center randomized controlled trial (RCT) that compared clinical outcomes of intermediate-risk NMIBC patients ...

7.

onclive.com

onclive.com/view/tyra-300-is-safe-generates-preliminary-antitumor-activity-in-fgfr3-metastatic-urothelial-cancer

TYRA-300 Is Safe, Generates Preliminary Antitumor ...

TYRA-300 was safe and produced preliminary antitumor activity in patients with metastatic urothelial cancer harboring FGFR3 alterations.