Back to resultsA Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Primary Purpose
Non-muscle-invasive Bladder Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STM-416
Sponsored by
About this trial
This is an interventional treatment trial for Non-muscle-invasive Bladder Cancer focused on measuring Open-label, Dose escalation, STM-416, Resiquimod, Toll-like receptor 7/8, Non-Muscle Invasive Bladder Cancer, TURBT, Immunotherapy, BCG
Eligibility Criteria
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: 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: 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. Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher; 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.
Sites / Locations
- Arizona Urology SpecialistsRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Carolina Urologic Research CenterRecruiting
- Urology Associates, P.C.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STM-416
Arm Description
STM-416
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05710848
Brief Title
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Official Title
A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SURGE Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-muscle-invasive Bladder Cancer
Keywords
Open-label, Dose escalation, STM-416, Resiquimod, Toll-like receptor 7/8, Non-Muscle Invasive Bladder Cancer, TURBT, Immunotherapy, BCG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Singe group assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STM-416
Arm Type
Experimental
Arm Description
STM-416
Intervention Type
Drug
Intervention Name(s)
STM-416
Intervention Description
STM-416 monotherapy
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1
Description
Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
Time Frame
21 days
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1
Description
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
Time Frame
Time on trial up to 90 days
Title
Recurrence free survival time (Phase 2a)
Description
Recurrence will be evaluated by cystoscopy and urine cytology
Time Frame
Through study completion up to 24 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics of STM-416 (Phase 1)
Description
Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood for the single dose level (Phase 1)
Time Frame
Day 0, post 24 hours, post 24 hour
Title
Pharmacokinetics of STM-416 (Phase 1)
Description
Area under the plasma concentration versus time curve (AUC) of resiquimod (R848) in patient blood for the single dose level (Phase 1)
Time Frame
Day 0, post 24 hours, post 24 hour
Title
Pharmacodynamics of STM-416
Description
Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level for Phase 1/2a
Time Frame
Day 0, post 24 hours, post 48 hours, post 21 days, post 90 days
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility 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 & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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:
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.
Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayti Aviano
Phone
781-605-8632
Email
kayti@surgetx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Lerner, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Urology Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Montijo
Email
cmontijo@arizonauro.com
First Name & Middle Initial & Last Name & Degree
Susan Kalota, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Gershman, MD
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Richardson
Email
Jrichardson@curcmb.com
First Name & Middle Initial & Last Name & Degree
Abhishek Srivastava, MD
Facility Name
Urology Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe Wallace
Email
jawallace@ua-pc.com
First Name & Middle Initial & Last Name & Degree
Gautam Jayram, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
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