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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06450106




Registration number
NCT06450106
Ethics application status
Date submitted
2/06/2024
Date registered
10/06/2024
Date last updated
27/06/2025

Titles & IDs
Public title
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
Scientific title
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Secondary ID [1] 0 0
STM-416p-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - STM-416p

Experimental: STM-416p - STM-416p


Treatment: Drugs: STM-416p
STM-416p monotherapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Timepoint [1] 0 0
21 Days
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [2] 0 0
Time on trial up to 90 days
Secondary outcome [1] 0 0
Pharmacokinetics of STM-416p
Timepoint [1] 0 0
Day 0, post 24 hours, post 48 hour
Secondary outcome [2] 0 0
Pharmacodynamics of STM-416p in blood circulating cytokines
Timepoint [2] 0 0
Day 0, post 24 hours, post 48 hours, post 21 days
Secondary outcome [3] 0 0
Assess surgical wound healing
Timepoint [3] 0 0
Day 7, Day 21

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian Prostate Center - Melbourne N.
Recruitment hospital [2] 0 0
Epworth HealthCare - Melbourne N.
Recruitment postcode(s) [1] 0 0
3051 - Melbourne N.
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SURGE Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kayti Aviano
Address 0 0
Country 0 0
Phone 0 0
781-605-8632
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06450106