Patient Eligibility

Study Overview

  • Study Name: SURF302
  • Status: Recruiting
  • Phase: Phase 2, open-label
  • Indication: FGFR3-altered, low-grade  intermediate-risk non–muscle invasive  bladder cancer (IR-NMIBC)
  • Estimated Enrollment: Up to 90 participants
  • Study Sites: Primarily U.S.
  • Clinicaltrials.gov ID: NCT06995677

Dosing and Design

  • Participants are placed into one of the study groups at random to receive:
    • 50 mg dabogratinib once daily (QD)
    • 60 mg dabogratinib once daily (QD)
  • Oral administration (tablet)
  • A third dosing cohort may be added after safety/efficacy review
Primary Endpoint
  • Complete Response (CR) Rate at 3 months
Secondary Endpoints
  • Median duration of response
  • Safety and tolerability

Rationale for Study
FGFR3 alterations are highly prevalent in IR-NMIBC, making FGFR3 an important therapeutic target. Dabogratinib is the only oral, highly selective FGFR3 inhibitor currently in clinical development for low grade IR-NMIBC and may offer a less invasive treatment option for this underserved patient population.

Key Inclusion Criteria
  • Adults (≥18 years) with histologically confirmed, low-grade IR-NMIBC
  • Participants with at least 3 mm and no more than 12 mm total residual visible tumor as a marker lesion(s) left behind:
    • Ta low grade tumor
    • T1 low grade tumor
  • Documented FGFR3 alteration
  • Testing through a study sponsored urine test
  • ECOG performance status 0–1
  • Adequate organ function as defined by protocol
Exclusion Criteria
  • Evidence of muscle-invasive (≥T2) or metastatic bladder cancer
  • High-grade disease or carcinoma in situ (CIS)
  • Prior exposure to FGFR inhibitors
  • Significant concurrent medical conditions or uncontrolled comorbidities
  • Pregnant or breastfeeding

Are you a physician interested in the study?
For questions please reach out to us directly at Tyraclinicaltrials@tyra.bio