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RecruitingLast updated: 17 December 2025

Stingray: Determining the recommended dose level, safety and effectiveness of a drug called SR-8541A in people with advanced or metastatic solid cancers.Phase 1, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of SR-8541A (ENPP1 Inhibitor) Administered Orally as Monotherapy in Subjects With Advanced/Metastatic Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

Stingray

Clinical summary

Summary

SR-8541A is a targeted drug that inhibits a protein called ENPP1. It is given orally by itself (monotherapy) and will be studied to assess how safe and tolerable it is, as well as how it interacts in the body, in people with advanced or metastatic solid cancers.

To be eligible for the study, people need to have cancer that is refractory (not responding to) standard therapeutic options, or for which there are no standard therapeutic options available.

The study will begin with a dose escalation part, where different dose levels of SR-8541A will be evaluated to determine the recommended dose level.

The next part, the combination part, of the study will only begin once the researchers have selected a safe recommended dose level to test further. In this part, people may also receive either nivolumab or pembrolizumab.

Conditions

This trial is treating people with advanced or metastatic solid cancers

Eligibility

Inclusion

  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

  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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Stingray Therapeutics

Scientific Title

Phase 1, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of SR-8541A (ENPP1 Inhibitor) Administered Orally as Monotherapy in Subjects With Advanced/Metastatic Solid Tumors

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