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

SURGE Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: STM-416p

Study type: Interventional

Funder types: Industry

Identifiers

NCT06450106

STM-416p-201

Details and patient eligibility

About

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

Full description

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

Enrollment: 18 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

STM-416p

Experimental group

Description:

STM-416p

Treatment:

Drug: STM-416p