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Tyrosine Kinase Inhibitor

TYRA-300 for Bladder Cancer (SURF301 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Tyra Biosciences, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1 Part A and Part B: Men and women 18 years of age or older with ECOG performance status of ≤1 and histologically confirmed advanced solid tumor who have exhausted standard therapeutic options. Must have evaluable (Part A) or measurable (Part B) disease according to RECIST v1.1. Also, histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment, every 8 or 12 weeks (up to 5 years).

Awards & highlights

SURF301 Trial Summary

This trial is studying the safety and effectiveness of a new drug, TYRA-300, for treating patients with bladder or urinary tract cancer that has spread to other parts of the body.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include risks related to high phosphorus levels, eye toxicity concerns, potential heart issues due to pre-existing conditions, brain metastases symptoms worsening, and gastrointestinal problems affecting the drug's intake.

SURF301 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You are a man or woman 18 years or older with a confirmed advanced solid tumor for which standard treatments have not worked. Your overall health status is good and your tumor can be measured or evaluated according to specific guidelines. Additionally, for Part B, you have a confirmed advanced solid tumor with a specific mutation in the FGFR3 gene.

SURF301 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment, every 8 or 12 weeks (up to 5 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment, every 8 or 12 weeks (up to 5 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment, every 8 or 12 weeks (up to 5 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1 Part A: To determine the maximum tolerated doses (MTD).

Phase 1 Part B: To determine the recommended Phase 2 dose (R2PD).

Phase 2: Overall Response Rate (ORR), defined by RECIST v1.1.

Secondary outcome measures

Disease

Duration of response will be defined as the time from the initial CR or PR to the time of relapse or death, whichever occurs first among participant with an objective response.

Frequency in changes in laboratory parameters and physical signs of toxicity.

+8 more

SURF301 Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 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 expansionExperimental Treatment1 Intervention

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

Group III: Phase 1 Part A - dose escalationExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tyra Biosciences, IncLead Sponsor

2 Previous Clinical Trials

100 Total Patients Enrolled

Hiroomi Tada, M.D., Ph.D.Study ChairTyra Biosciences, Inc

2 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

TYRA-300 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05544552 — Phase 1 & 2

Bladder Cancer Research Study Groups: Phase 1 Part A - dose escalation, Phase 1 Part B - dose expansion, Phase 2

Bladder Cancer Clinical Trial 2023: TYRA-300 Highlights & Side Effects. Trial Name: NCT05544552 — Phase 1 & 2

TYRA-300 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05544552 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are you enrolling people in this clinical trial right now?

"Yes, as of today this trial is still recruiting patients. The listing was first posted on November 1st, 2020 and updated two weeks ago on the 14th."

Answered by AI

Are there any research facilities in North America testing this hypothesis?

"8 hospitals are currently recruiting patients for this clinical trial. If you choose to enroll, it would be beneficial to select the clinic that is closest to your residence in order to reduce travel demands. The 8 locations include: Nashville, Boston, Durham and 5 others."

Answered by AI

How many people will be included in this clinical trial?

"To successfully complete this clinical trial, 310 patients that fit the certain prerequisites must be willing to participate. These participants may come from Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville in Nashville, Tennessee or Dana Farber Cancer Institute in Boston, Massachusetts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

2022. "Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05544552.