Clinical trial Recruiting at 3 sites Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment25 (estimated)
SponsorStingray Therapeutics
Industry-sponsored
Drugs / interventionsradiation, prednisone, nivolumab, pembrolizumab
Locations3 sites (Randwick, New South Wales and 2 other locations)
StatusRecruiting
StartedOctober 12, 2023
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedJune 8, 2025
Trial IDNCT06063681 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Treatment for advanced colorectal cancer using a new drug combination

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.