A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

Part of paid clinical trials in Mesa, Arizona.

Sponsor
SURGE Therapeutics
Study ID
NCT05710848
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Non-muscle-invasive Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STM-416 — DRUG
    STM-416 monotherapy

Study Details

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.

Key Dates

Start date
Jul 11, 2023
Status verified
May 2026
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: STM-416
    STM-416

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1 [ Time Frame: 21 days ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
East Valley Urology Center of ArizonaMesaArizona85206
Alekhya Padavala
Harpreet Wadhwa (PRINCIPAL_INVESTIGATOR)
Arizona Urology SpecialistsTucsonArizona85715-
Arkansas UrologyLittle RockArkansas72211
Katie O'Brien
Jonathan Henderson, MD (PRINCIPAL_INVESTIGATOR)
Unio Specialty Care - A Genesis Healthcare Partners FacilityBakersfieldCalifornia93301
Evelyn De La Cruz
Michael Oefelein, MD (PRINCIPAL_INVESTIGATOR)
Genesis ResearchDowneyCalifornia90241
Michelle Martinez
Sepehr Nowfar, MD (PRINCIPAL_INVESTIGATOR)
Urology Center of Southern CaliforniaMurrietaCalifornia28078
Laura Guerrero
Madhumitha Reddy, MD (PRINCIPAL_INVESTIGATOR)
Advanced Urology InstituteDaytona BeachFlorida32114
Sara Esposito
Samuel Lawindy, MD (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32608
Padraic O'Malley, MD (PRINCIPAL_INVESTIGATOR)
Advent HealthOrlandoFlorida32803
Genevieve Rexford
[email protected]
Zachary Smith, MD (PRINCIPAL_INVESTIGATOR)
Anna Arundel UrologyAnnapolisMaryland21410
Megan Lormore
Mara Holton, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Nnamdi Onochie
[email protected]
Matthew Mossanen, MD (PRINCIPAL_INVESTIGATOR)
Michigan Institute of UrologyTroyMichigan48084
Danielle Osterhout
Jason Hafron, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43221
Audrey Knight
[email protected]
Debasish Sundi, MD (PRINCIPAL_INVESTIGATOR)
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572
Rikki Waldorf
[email protected]
Abhishek Srivastava, MD (PRINCIPAL_INVESTIGATOR)
Lowcountry UrologyNorth CharlestonSouth Carolina29406
Madalyn Colbert
Justin Ellett, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Corey Nixon
corey.nixon@UTsouthwestern.eduUTsouthwestern.eduTSouthwestern.edu
Yair Lotan, MD (PRINCIPAL_INVESTIGATOR)
Urology Partners of North TexasFort WorthTexas76132
Grace Yoon
Adam Hollander, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Rosalind Mouton
[email protected]
Seth Paul Lerner, MD (PRINCIPAL_INVESTIGATOR)
Houston MethodistHoustonTexas77030
Karina Lozano
[email protected]
Dharam Kaushik, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Hannah Landry
[email protected]
Ahmed Mansour, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Mesa, AZ

By research site
East Valley Urology Center of Arizona· Mesa, AZArizona Urology Specialists· Tucson, AZArkansas Urology· Little Rock, ARUnio Specialty Care - A Genesis Healthcare Partners Facility· Bakersfield, CAGenesis Research· Downey, CAUrology Center of Southern California· Murrieta, CA

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