Clinical trial · Interventional
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
NCT06450106CI-TRIAL-00103658recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STM-416p | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STM-416p
- description
- STM-416p
- interventionNames
- Drug: STM-416p
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
- timeFrame
- 21 Days
- description
- Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- Time on trial up to 90 days
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.