A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Recruiting
Phase 1Phase 2Interventional Study
Non-muscle-invasive Bladder Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
SURGE Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with bladder cancer who have had previous treatments and are scheduled for a specific surgery. Participants will receive STM-416 to help understand its safety and how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have high-grade non-muscle-invasive bladder cancer.
I have had repeated bladder issues after treatment.
I am considered at high risk for cancer to come back.
I can perform daily activities with some help if needed.
My blood tests show I have enough healthy cells.
I am having surgery without additional chemotherapy.
You may not be able to join if
I have had muscle-invasive bladder cancer.
I am taking any other experimental treatments.
I am allergic to similar medications or ingredients in STM-416.
I have an uncontrolled illness that affects my condition.
I am a woman who could become pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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…
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 × 109/L (75,000 per mm3);
* Serum bilirubin 1.5 × institutional upper limit of normal (ULN);
* AST (serum glutamic-oxaloacetic transaminase)/ALT (serum glutamic-pyruvic transaminase) 2.5 × institutional ULN; and
* Creatinine CL 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL: Males: Creatinine CL (mL/min) = Weight (kg) × (140 - Age)/72 × serum creatinine (mg/dL); or Females: Creatinine CL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL).
Exclusion Criteria:
1. Have a history of CIS or MIBC;
2. Are receiving any other investigational agents;
3. 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;
4. 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.
Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher;
5. 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.
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