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

Prostate Cancer Clinical Trial

Official title:

A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450106
• Other study ID #: STM-416p-201
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 2024
• Est. completion date: March 2026

Study information

• Verified date: June 2024
• Source: SURGE Therapeutics
• Contact: Kayti Aviano
• Phone: 781-605-8632
• Email: kayti[@]surgetx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• STM-416p
STM-416p monotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SURGE Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]	Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment	21 Days
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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	Time on trial up to 90 days
Secondary	Pharmacokinetics of STM-416p	Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood	Day 0, post 24 hours, post 48 hour
Secondary	Pharmacodynamics of STM-416p in blood circulating cytokines	Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level	Day 0, post 24 hours, post 48 hours, post 21 days
Secondary	Assess surgical wound healing	Assessment of wound healing scored according to a modified ASEPSIS method	Day 7, Day 21