Recruiting NCT06450106
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STM-416p.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Overview
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
- Drug STM-416p
STM-416p monotherapy
Primary outcome measures
- Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] [Time frame: 21 Days]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: Time on trial up to 90 days]
Secondary outcome measures (3)
- Pharmacokinetics of STM-416p [Time frame: Day 0, post 24 hours, post 48 hour]
- Pharmacodynamics of STM-416p in blood circulating cytokines [Time frame: Day 0, post 24 hours, post 48 hours, post 21 days]
- Assess surgical wound healing [Time frame: Day 7, Day 21]
Eligibility criteria
Inclusion criteria
- Males aged 18 years or older at time of informed consent.
- Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
- Grade Group 2-5.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
- Have adequate organ and bone marrow function at screening.
- Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document
Exclusion criteria
- Have an invasive malignancy, other than the disease under study.
- Anticipated to require the use of a drain after radical prostatectomy.
- 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.
- 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.
- History of allogeneic organ transplant.
- History of primary immunodeficiency.
- QTc interval >470 msec at Screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Arizona Urology Specialists — Tucson
- University of Florida — Gainesville
Australia · 2 centers
- Australian Prostate Center — Melbourne N.
- Epworth HealthCare — Melbourne N.
Identifiers
NCT: NCT06450106 · STM-416p-201