Testing SR-8541A for advanced solid tumors
Official title: Phase 1, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of SR-8541A (ENPP1 Inhibitor) Administered Orally as Monotherapy or in Combination With Checkpoint Inhibitors in Subjects With Advanced/Metastatic Solid Tumors
Run by Stingray Therapeutics · NCT06063681 · Data updated 2026-11-12
This study is testing a new drug called SR-8541A to see if it can help people with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Stingray Therapeutics Industry-sponsored |
| Drugs / interventions | radiation, prednisone, nivolumab, pembrolizumab |
| Locations | 3 sites (Randwick, New South Wales and 2 other locations) |
| Status | Recruiting |
| Started | October 12, 2023 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | June 8, 2025 |
| Trial ID | NCT06063681 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with advanced solid tumors that are refractory to standard treatments and have a life expectancy of at least 3 months.
✕Probably not a fit
Patients with primary central nervous system tumors or those who have had recent systemic anti-cancer treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, dose-escalation phase 1 study evaluates the safety, tolerability, and pharmacokinetics of SR-8541A, an ENPP1 inhibitor, in patients with advanced or metastatic solid tumors. Participants will receive SR-8541A orally, either alone or in combination with an immune checkpoint inhibitor, depending on safety assessments. The study aims to enroll approximately 10 subjects whose tumors are refractory to standard treatments or for whom no standard options exist. Treatment will continue until disease progression or other discontinuation criteria are met.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have not responded to existing therapies.
How similar studies have gone: While this approach is novel, similar studies evaluating ENPP1 inhibitors have shown promise in early phases.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Life expectancy of at least 3 months 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 3. Histopathologically/cytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options. 4. Measurable disease per RECIST v1.1 5. Willing to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional) 6. Adequate hematologic, renal and hepatic function Exclusion Criteria: 1. Primary central nervous system (CNS) tumor 2. Prior systemic anti-cancer treatment including other investigational agents, surgery, or radiation within 28 days or 5 half-lives, whichever is less 3. Continuous systemic treatment with either corticosteroids (\>10 milligram \[mg\] daily prednisone equivalents) or other immunosuppressive medications within 28 days 4. Active autoimmune disease that has required systemic treatment in past 2 years 5. History of documented congestive heart failure (New York Heart Association \[NYHA\] class II - IV); unstable angina; poorly controlled hypertension; clinically significant valvular heart disease; high-risk uncontrolled arrhythmias (including sustained ventricular tachycardia); myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the last 6 months, or Canadian Cardiovascular Society angina class \> 2 6. Troponin I \> ULN 7. Blood pressure (BP) - Systolic \< 95 mmHg or \> 160 mmHg or diastolic \> 100 mmHg 8. Resting heart rate (HR) \> 100 beats per minute (BPM) 9. Corrected QT interval by Fridericia (QTcF) ≥ 470 ms 10. Left Ventricular Ejection Fraction (LVEF) \< 50% 11. Symptomatic uncontrolled CNS disease requiring treatment with steroids or anti-seizure medications within 2 months 12. Leptomeningeal disease 13. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 8 weeks 14. Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment 15. Prior additional malignancy that is progressing or has received treatment the previous 3 years 16. Active infection requiring systemic treatment 17. Positive for human immunodeficiency virus (HIV) (HIV antibodies) or active hepatitis B (e.g., HbsAg reactive) or active hepatitis C (e.g., HCV ribonucleic acid \[RNA\] qualitative) infection with detectable viral load 18. Major surgery within 28 days prior to Day 1 and/or minor surgery (excluding biopsy) within 7 days
Where it's running
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Scientia Clinical Research Ltd
Randwick, New South Wales, Australia Recruiting -
Monash Health
Clayton, Victoria, Australia Recruiting -
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia Recruiting
Study contacts
- Principal investigator: Vinod Ganju, MD — Peninsula & South Eastern Haematology & Oncology Group
- Study coordinator: Sunil Sharma
- Email: Sunil Sharma <ssharma@honorhealth.com>
- Phone: 602-343-8402
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.