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.
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 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.
Single group
STM-416
DrugSTM-416 monotherapy
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1
Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1
Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Recurrence free survival time (Phase 2a)
Recurrence will be evaluated by cystoscopy and urine cytology
Pharmacokinetics of STM-416 (Phase 1)
Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood for the single dose level (Phase 1)
Pharmacokinetics of STM-416 (Phase 1)
Area under the plasma concentration versus time curve (AUC) of resiquimod (R848) in patient blood for the single dose level (Phase 1)
Pharmacodynamics of STM-416
Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level for Phase 1/2a
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