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

Phase 1

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: STM-416p

• Registration Number: NCT06450106
• Lead Sponsor: SURGE Therapeutics

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

Study Timeline

• Study First Submitted: 2024-06-02
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Study Start: 2025-01
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STM-416p	STM-416p	STM-416p

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Assess surgical wound healing	Day 7, Day 21	Assessment of wound healing scored according to a modified ASEPSIS method
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
Pharmacokinetics of STM-416p	Day 0, post 24 hours, post 48 hour	Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood