Trial Title:
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
NCT ID:
NCT05710848
Condition:
Non-muscle-invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
Open-label
Dose escalation
STM-416
Resiquimod
Toll-like receptor 7/8
Non-Muscle Invasive Bladder Cancer
TURBT
Immunotherapy
BCG
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Singe group assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
STM-416
Description:
STM-416 monotherapy
Arm group label:
STM-416
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.
Detailed description:
This is a 2-part, multicenter, first-in-human (FIH), Phase 1/2a study in patients with 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. All patients will
receive relevant SOC therapy following TURBT. SOC will be administered in the adjuvant
setting.
Phase 1 is an open-label, single-treatment, dose-escalation study to evaluate the safety
and tolerability of up to 4 increasing doses of intraoperatively administered STM-416
utilizing a 3+3 convention, with 3 to 6 patients enrolled in each STM-416 dose level,
with a minimum of 6 patients enrolled at the highest dose level, for a total of
approximately 24 patients.
Phase 2a is a randomized, single-blind, single-treatment, dose-expansion study that will
comprise 2 arms: TURBT + STM-416 Dose 1 followed by SOC versus TURBT + STM-416 Dose 2
followed by SOC.
Criteria for 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;
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.
Gender:
All
Gender based:
Yes
Gender description:
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.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Urology Specialists
Address:
City:
Tucson
Zip:
85715
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Montijo
Email:
cmontijo@arizonauro.com
Investigator:
Last name:
Susan Kalota, MD
Email:
Principal Investigator
Facility:
Name:
University of Florida
Address:
City:
Gainesville
Zip:
32608
Country:
United States
Status:
Recruiting
Contact:
Last name:
Casey Walsh
Email:
CaseyWalsh@cancer.ufl.edu
Investigator:
Last name:
Padraic O'Malley, MD
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Boris Gershman, MD
Email:
Principal Investigator
Facility:
Name:
Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shawna Pochan
Email:
shawna.pochan@duke.edu;
Investigator:
Last name:
Michael Abern, MD
Email:
Principal Investigator
Facility:
Name:
The Ohio State University
Address:
City:
Columbus
Zip:
43221
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kendall Lewis
Email:
Kendall.Lewis@osumc.edu
Investigator:
Last name:
Kamal Pohar, MD
Email:
Principal Investigator
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Richardson
Email:
Jrichardson@curcmb.com
Investigator:
Last name:
Abhishek Srivastava, MD
Email:
Principal Investigator
Facility:
Name:
Urology Associates, P.C.
Address:
City:
Nashville
Zip:
37209
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joe Wallace
Email:
jawallace@ua-pc.com
Investigator:
Last name:
Gautam Jayram, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jose Santoyo
Email:
Jose.Santoyo@UTSouthwestern.edu
Investigator:
Last name:
Yair Lotan, MD
Email:
Principal Investigator
Facility:
Name:
Baylor College of Medicine
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sharon Harrison
Email:
sharons@bcm.edu
Investigator:
Last name:
Seth Paul Lerner, MD
Email:
Principal Investigator
Facility:
Name:
Houston Methodist
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Taliah Muhammad
Email:
tnmuhammad@houstonmethodist.org
Investigator:
Last name:
Raj Satkunasivam, MD
Email:
Principal Investigator
Start date:
July 11, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
SURGE Therapeutics
Agency class:
Industry
Source:
SURGE Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05710848
