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Trial Title:
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
NCT ID:
NCT06450106
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Intraoperative
Dose escalation
Open-label
STM-416
Resiquimod
Toll-like receptor 7/8
Radical prostatectomy
Robotic prostatectomy
Immunotherapy
STM-416p
PSA
R848
Hydrogel
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single group assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
STM-416p
Description:
STM-416p monotherapy
Arm group label:
STM-416p
Summary:
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical
Prostatectomy
Detailed description:
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients
Undergoing Radical Prostatectomy
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2024
Completion date:
March 2026
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/NCT06450106
