Testing SR-8541A for advanced solid tumors

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

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: PHASE1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stingray Therapeutics (industry)
• Drugs / interventions: radiation, prednisone, nivolumab, pembrolizumab
• Locations: 3 sites (Randwick, New South Wales and 2 other locations)
• Trial ID: NCT06063681 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While this approach is novel, similar studies evaluating ENPP1 inhibitors have shown promise in early phases.

Eligibility 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 this trial is running

Randwick, New South Wales and 2 other locations

• 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

Conditions: Advanced / Metastatic Solid Tumor, Refractory, Relapsing, Solid Tumors