RecruitingPhase 1/2

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

United States75 participantsStarted 2023-07-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Are aged 18 years or older;
✓. 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;
✓. Are considered high risk for recurrence;
✓. Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;
✓. Have adequate organ and marrow function as defined below:

Exclusion criteria

✕. Have a history of CIS or MIBC;
✕. Are receiving any other investigational agents;
✕. Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate;
✕. Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
✕. Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and Phase 2a to avoid bias due to the low prevalence of NMIBC in this population. However, they will be included in subsequent Phase 2/3 studies.

What they're measuring

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1

Timeframe: 21 days

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1

Timeframe: Time on trial up to 90 days

Recurrence free survival time (Phase 2a)

Timeframe: Through study completion up to 24 months

Trial details

NCT IDNCT05710848

SponsorSURGE Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Kayti Aviano

781-605-8632 kayti@surgetx.com

View on ClinicalTrials.gov More Non-muscle-invasive Bladder Cancer trials