TYRA-300 for Bladder Cancer

(SURF301 Trial)

Recruiting at 21 trial locations

Overseen By Grace Indyk

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Tyra Biosciences, Inc

Disqualifiers: Uncontrolled cardiovascular disease, Brain metastases, Gastrointestinal disorders, others

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

Compensation: Varies

Number of Visits: Unknown

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called TYRA-300, a potential drug for individuals with certain types of advanced bladder and other solid tumors. Researchers aim to determine if TYRA-300 is safe and effective and how it moves through the body. The trial includes different parts to test TYRA-300 at various doses. Suitable candidates have an advanced solid tumor with specific FGFR3 gene changes and have exhausted all standard treatments. As a Phase 1 trial, this research focuses on understanding how TYRA-300 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that TYRA-300 was safe in earlier studies. Early results indicate that people tolerate TYRA-300 well. In studies with patients who have FGFR3-altered cancers, 54.5% experienced tumor shrinkage, and all patients maintained disease control with doses of 90 mg per day or more. This suggests the treatment is generally safe, with manageable side effects. As a daily pill, it is easy to take. While these results are encouraging, it is important to note that the study remains in its early stages, and further research will provide a clearer picture of its safety. ^{1 2 3 4 5}

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

TYRA-300 is unique because it is administered orally, simplifying treatment compared to some current options for bladder cancer, which often involve intravenous delivery or surgical procedures. Unlike traditional therapies that target broad cancer cell functions, TYRA-300 is designed to target specific molecular pathways, potentially offering a more precise attack on cancer cells while sparing healthy ones. Researchers are excited because this targeted approach could lead to fewer side effects and improved outcomes for patients.

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

Research shows that TYRA-300 has promising early results for treating cancers with changes in the FGFR3 gene. Previous studies found that patients generally tolerated TYRA-300 well, with few side effects related to other FGFR issues. Early data suggests that the treatment may be effective against tumors, particularly in the bladder and urinary tract. Participants in these studies experienced encouraging safety and initial effectiveness. Overall, TYRA-300 seems to offer a hopeful option for those with advanced cancers linked to FGFR3 changes. ^{1 6 7 8 9}

Who Is on the Research Team?

Doug Warner

Principal Investigator

Tyra Biosciences, Inc

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including bladder cancer, that have run out of standard treatment options. They must be in relatively good health (ECOG ≤1) and have a specific FGFR3 gene alteration. Children over 12 can join Phase 2 if they're mostly healthy (KPS >70). Pregnant or breastfeeding individuals and those planning to conceive are excluded.

Inclusion Criteria

I am 12 or older with a certain level of physical ability and have at least one measurable tumor.

Exclusion Criteria

Your blood has too much phosphorus, even after trying to fix it with medicine.

I have an eye condition that could worsen with treatment.

I do not have any uncontrolled heart conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Participants receive TYRA-300 in 28-day cycles starting at 10 mg daily to determine the optimal and maximum tolerated dose

Varies based on dose escalation

Regular visits for dose monitoring

Phase 1 Dose Expansion

Participants receive TYRA-300 in 28-day cycles at doses determined during dose escalation

Varies based on dose expansion

Regular visits for safety and tolerability assessment

Phase 2

Participants receive TYRA-300 in 28-day cycles to evaluate preliminary antitumor activity

Varies based on treatment response

Regular visits for antitumor activity assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TYRA-300

Trial Overview TYRA-300 is being tested for safety and its ability to shrink tumors in patients with certain genetic changes in their cancer cells. The study will also look at how the body processes the drug. It's aimed at people whose cancers haven't responded to other treatments.

How Is the Trial Designed?

Group I: Phase 2 Experimental Treatment 1 Intervention

TYRA-300 taken once or twice daily by mouth in 28-day cycles at doses determined during Phase 1.

Group II: Phase 1 Part B - dose expansion Experimental Treatment 1 Intervention

TYRA-300 taken once or twice daily by mouth in 28-day cycles.

Group III: Phase 1 Part A - dose escalation Experimental Treatment 1 Intervention

TYRA-300 taken once daily by mouth in 28-day cycles starting at 10 mg daily.

Who Is Running the Clinical Trial?

Tyra Biosciences, Inc

Lead Sponsor

Trials

4

Recruited

500+

Citations

1. 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 ... TYRA-300 is an investigational, daily oral tablet that has shown encouraging preliminary safety and efficacy in an early phase trial and has ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06995677?term=TYR300-202&rank=1

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

3. 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 ... Preliminary data from SURF301 suggest TYRA-300 to be generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities.

4. urologytimes.com urologytimes.com/view/phase-2-trial-of-tyra-300-launches-in-lg-ir-nmibc

Phase 2 trial of TYRA-300 launches in LG-IR-NMIBC Overall, TYRA-300 demonstrated promising initial clinical activity while maintaining a favorable tolerability profile in patients with ...

5. 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 ... TYRA-300 is an investigational, daily oral tablet that has shown encouraging preliminary safety and efficacy in an early phase trial and has ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05544552

Safety and Preliminary Anti-Tumor Activity of TYRA-300 in ... The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 ...

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 Activity ... TYRA-300 showed a 54.5% partial response rate and 100% disease control in FGFR3-altered metastatic urothelial cancer at ≥90 mg/day. · The ...

8. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/bladder-cancer/163850-tyra-biosciences-doses-first-patient-in-phase-2-study-of-tyra-300-in-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer-surf302.html

Tyra Biosciences Doses First Patient in Phase 2 Study of ... TYRA-300 is an investigational, daily oral tablet that has shown encouraging preliminary safety and efficacy in an early phase trial and has the ...

9. 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 TYRA-300 is an investigational, daily oral tablet that has shown encouraging preliminary safety and efficacy in an early phase trial and has the ...