Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06450106
Other study ID # STM-416p-201
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date September 2024
Est. completion date March 2026

Study information

Verified date June 2024
Source SURGE Therapeutics
Contact Kayti Aviano
Phone 781-605-8632
Email kayti@surgetx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy


Description:

A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date March 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Males aged 18 years or older at time of informed consent. 2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening. 3. Grade Group 2-5. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status =2 at Screening. 5. Have adequate organ and bone marrow function at screening. 6. Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document Exclusion Criteria: 1. Have an invasive malignancy, other than the disease under study. 2. Anticipated to require the use of a drain after radical prostatectomy. 3. Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate. 5. History of allogeneic organ transplant. 6. History of primary immunodeficiency. 7. QTc interval >470 msec at Screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
STM-416p
STM-416p monotherapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
SURGE Therapeutics

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment 21 Days
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 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 on trial up to 90 days
Secondary Pharmacokinetics of STM-416p Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood Day 0, post 24 hours, post 48 hour
Secondary Pharmacodynamics of STM-416p in blood circulating cytokines Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level Day 0, post 24 hours, post 48 hours, post 21 days
Secondary Assess surgical wound healing Assessment of wound healing scored according to a modified ASEPSIS method Day 7, Day 21
See also
  Status Clinical Trial Phase
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A