A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer
SURGE Therapeutics
Summary
This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.
Description
This is a 2-part, multicenter, first-in-human (FIH), Phase 1/2a study in patients with a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy. All patients will receive relevant SOC therapy following TURBT. SOC will be administered in the adjuvant setting. Phase 1 is an open-label, single-treatment, dose-escalation study to evaluate the safety and tolerability of up to 6 increasing doses of intraoperatively ad…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Are aged 18 years or older; 2. Have a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy; 3. Are considered high risk for recurrence; 4. Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2; 5. Have adequate organ and marrow function as defined below: * Hemoglobin 9.0 g/dL; * Absolute neutrophil count 1.5 × 109/L (1500 per mm3); * Platelet count 75…
Interventions
- DrugSTM-416
STM-416 monotherapy
Locations (10)
- Arizona Urology SpecialistsTucson, Arizona
- University of FloridaGainesville, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Duke Cancer CenterDurham, North Carolina
- The Ohio State UniversityColumbus, Ohio
- Carolina Urologic Research CenterMyrtle Beach, South Carolina