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

 A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 (Dabogratinib) in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)

INTRODUCTION:
Org Study ID: TYR300-202
Secondary ID: N/A
NCT ID: 06995677
Sponsor: Tyra Biosciences, Inc.

The SURF302 study is a marker lesion study evaluating TYRA-300 (Dabogratinib) for the first time in patients with low grade, intermediate risk, non-muscle invasive bladder cancer who have FGFR3 gene alterations in their tumors.

Dabogratinib is being developed as an oral therapy that targets specific alterations (or abnormalities) in the FGFR3 gene. The FGFR3 gene is altered in up to 80% of non-muscle invasive bladder cancer. Tumors with these alterations can respond to drugs that target FGFR3. Other experimental drugs targeting FGFR3 also target other FGFR family members, which may lead to side effects that can interfere with quality of life or result in treatment discontinuation. In addition, tumors being treated with these medicines can become resistant to these drugs by mutating. Dabogratinib was designed to be more selective for FGFR3 and less likely fail despite the presence of specific mutations. Moreover, by closely targeting the FGFR3 gene, it is believed the development of certain side effects may be reduced.

BRIEF SUMMARY
The purpose of this study is to evaluate the efficacy, safety/tolerability, and pharmacokinetics (PK) of Dabogratinib in low grade, intermediate risk non-muscle invasive bladder cancer with FGFR3 activating gene alterations.

DETAILED DESCRIPTION
SURF302 is an open-label, Phase 2, marker lesion study evaluating the efficacy and safety of Dabogratinib in participants with FGFR3-altered, low-grade, intermediate-risk (IR) NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with Dabogratinib at 50 mg once-daily (QD) (Cohort 1) or treatment with Dabogratinib at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability.

OVERALL STATUS:
Recruiting
Start Date: 27 Jun 2025
Phase 2
Study Type: Interventional

PRIMARY OUTCOMES
Primary Outcome 1 - Measure: Complete response (CR) rate at 3 months
Secondary Outcome 1- Measure: Duration of response in responders only
Secondary Outcome 2- Measure: Time to recurrence in responders only
Secondary Outcome 3- Measure: Recurrence-free survival at 12 months and 24 months in responders only
Secondary Outcome 4- Measure: Progression-free survival (all participants)
Secondary Outcome 5- Measure: Safety and tolerability

CONDITION
Non-muscle invasive bladder cancer
Solid Tumor
Urothelial Carcinoma
Adult
Bladder Cancer
FGFR3 Gene Mutation
FGFR3 Gene Alteration
Urinary Tract Cancer
Urinary Tract Tumor
Urinary Tract Carcinoma


ELIGIBILITY
Key Inclusion Criteria:

  1.  Age ≥ 18 at the time of informed consent
  2. Confirmed low grade NMIBC
  3. Intermediate risk NMIBC as per AUA Guidelines
  4. FGFR3 mutation or fusion
  5. No evidence of disease in the upper urinary tract or prostatic urethra
  6. No prior BCG administration within 1 year of date of consent
  7. ECOG 0-1
  8. Adequate bone marrow, liver, and renal function


Key Exclusion Criteria:

  1. Current or previous history of muscle invasive bladder cancer
  2. Current or previous history of lymph node positive and/or metastatic bladder cancer
  3. Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
  4. Current or history of receiving a prior FGFR inhibitor
  5. Systemic immunotherapy within 6 months prior to randomization
  6. Prior treatment with an intravesical agent within 8 weeks of baseline

Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No


OFFICIAL INFORMATION
Name: Doug Warner
Role: Study Chair
Affiliation: Tyra Biosciences, Inc

OVERALL CONTACT
Name: Grace Indyk
Phone: (619)728-4805
Email: [email protected]