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RecruitingLast updated: 5 April 2024

Stingray: This study aims to determine the recommended dose level, safety and effectiveness of a new 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

Clinical summary

Summary

Eligible participants will receive the drug SR-8541A, which is a ENPP1 inhibitor, daily administered orally.

The study will follow an accelerated titration dose (ATD) escalation scheme and assess the safety, tolerability, and pharmacokinetics of SR-8541A.

Treatment may continue until a participant's disease worsens or another treatment discontinuation criterion is met.

Conditions

This trial is treating patients with advanced or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

Stingray

More information

Trial Identifiers

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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

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

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • 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.

Ask your doctor if this trial could be right for you.

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