Actively Recruiting
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
Led by Stingray Therapeutics · Updated on 2025-06-08
25
Participants Needed
3
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint inhibitor (ICI) in subjects with solid tumors.
CONDITIONS
Official Title
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy of at least 3 months
- ECOG performance status 0 or 1
- Histopathologically or cytologically confirmed advanced solid tumor refractory to standard treatments or with no standard treatment options
- Measurable disease according to RECIST v1.1
- Willing to provide archival or fresh tumor tissue during screening and optionally post-treatment
- Adequate blood, kidney, and liver function
You will not qualify if you...
- Primary central nervous system tumor
- Systemic anti-cancer treatment, surgery, or radiation within 28 days or 5 half-lives, whichever is less
- Continuous systemic corticosteroids over 10 mg prednisone daily or other immunosuppressive drugs within 28 days
- Active autoimmune disease treated systemically in past 2 years
- History of significant heart conditions or recent cardiovascular events within 6 months
- Troponin I above upper limit of normal
- Blood pressure outside 95-160 mmHg systolic or over 100 mmHg diastolic
- Resting heart rate over 100 beats per minute
- Corrected QT interval by Fridericia 470 ms or higher
- Left ventricular ejection fraction below 50%
- Symptomatic uncontrolled central nervous system disease needing steroids or anti-seizure drugs within 2 months
- Leptomeningeal disease
- Untreated or unstable spinal cord compression
- Bleeding disorders or anticoagulation that cannot be quickly reversed
- Progressing additional malignancy or treated within past 3 years
- Active infection needing systemic treatment
- Positive for HIV or active hepatitis B or C with detectable viral load
- Major surgery within 28 days or minor surgery (excluding biopsy) within 7 days prior to Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
3
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia, 3199
Actively Recruiting
Research Team
S
Sunil Sharma
CONTACT
J
Jonathan Northrup
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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