Prostate Cancer
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
Brief 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
Interventions
DRUGSTM-416p
STM-416p monotherapy
Sponsors
SURGE Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group assignment
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] | 21 Days | Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Time on trial up to 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of STM-416p | Day 0, post 24 hours, post 48 hour | Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood |
| Pharmacodynamics of STM-416p in blood circulating cytokines | Day 0, post 24 hours, post 48 hours, post 21 days | Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level |
| Assess surgical wound healing | Day 7, Day 21 | Assessment of wound healing scored according to a modified ASEPSIS method |
Countries
Australia, United States
Contacts
CONTACTKayti Aviano
Outcome results
None listed