A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors

Last updated: June 4, 2025
Sponsor: Stingray Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Immune checkpoint inhibitor (ICI)

SR-8541A

Clinical Study ID

NCT06063681
StingrayTx
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 isrefractory to standard therapeutic options, or for which there are no standardtherapeutic options.

  4. Measurable disease per RECIST v1.1

  5. Willing to provide archival or fresh tumor tissue during screening (required) andpost-treatment (optional)

  6. Adequate hematologic, renal and hepatic function

Exclusion

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] dailyprednisone 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; clinicallysignificant valvular heart disease; high-risk uncontrolled arrhythmias (includingsustained ventricular tachycardia); myocardial infarction, unstable angina,cerebrovascular accident, or transient ischemic attack within the last 6 months, orCanadian 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 oranti-seizure medications within 2 months

  12. Leptomeningeal disease

  13. Spinal cord compression not definitively treated with surgery and/or radiation orpreviously diagnosed and treated spinal cord compression without evidence thatdisease has been clinically stable for at least 8 weeks

  14. Bleeding diathesis due to underlying medical condition or anticoagulation medicationwhich is unable to be promptly reversed by medical treatment

  15. Prior additional malignancy that is progressing or has received treatment theprevious 3 years

  16. Active infection requiring systemic treatment

  17. Positive for human immunodeficiency virus (HIV) (HIV antibodies) or active hepatitisB (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

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Immune checkpoint inhibitor (ICI)
Phase: 1
Study Start date:
October 12, 2023
Estimated Completion Date:
December 31, 2025

Study Description

SR-8541A, an ENPP1 inhibitor, will be administered orally as a monotherapy to assess safety, tolerability, and pharmacokinetics (PK) in subjects with advanced/metastatic solid tumors.

Subjects eligible for treatment include those whose disease is refractory to standard therapeutic options, or for which there are no standard therapeutic options available.

All enrolled patients will orally administer SR-8541A daily. Treatment may continue until the subject's disease worsens or another treatment discontinuation criterion is met.

The combination part will only commence once the SRC has deemed it safe to proceed and a SR-8541A dose from the dose escalation part is selected as the RP2D. The ICI will be either nivolumab or pembrolizumab and dosing will be per SOC. Both investigational products will start on C1D1. Treatment with ICI may be continued if SR-8541A is discontinued and treatment with SR-8541A may be continued after ICI is discontinued.

Approximately 10 subjects will be enrolled.

Connect with a study center

  • Scientia Clinical Research Ltd

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Peninsula & South Eastern Haematology & Oncology Group

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

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