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New treatment option for Non-muscle-invasive Bladder Cancer
Official title A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
ClinicalTrials.gov ID: NCT05710848
What this study is testing
What is STM-416?
STM-416 is an investigational medicine, being studied as a potential treatment for non-muscle-invasive bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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:
You likely can't join if
- 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...
- Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable...
- Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and...
See the full eligibility 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...
- 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:
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Mesa, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Bakersfield, California, United States
- Downey, California, United States
- Murrieta, California, United States
- Daytona Beach, Florida, United States
- Gainesville, Florida, United States
- Orlando, Florida, United States
- Annapolis, Maryland, United States
- Boston, Massachusetts, United States
- Troy, Michigan, United States
- Columbus, Ohio, United States
- Myrtle Beach, South Carolina, United States
- North Charleston, South Carolina, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mesa, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Bakersfield, California, United States; Downey, California, United States; Murrieta, California, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.