NCT06063681 A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
| NCT ID | NCT06063681 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Stingray Therapeutics |
| Condition | Advanced / Metastatic Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-10-12 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2023-10-12 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Vinod Ganju, MD
PRINCIPAL INVESTIGATOR
Peninsula & South Eastern Haematology & Oncology Group
Frequently Asked Questions
Who can join the NCT06063681 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced / Metastatic Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06063681 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06063681 currently recruiting?
Yes, NCT06063681 is actively recruiting participants. Contact the research team at Sunil Sharma <ssharma@honorhealth.com> for enrollment information.
Where is the NCT06063681 trial being conducted?
This trial is being conducted at Randwick, Australia, Clayton, Australia, Frankston, Australia.
Who is sponsoring the NCT06063681 clinical trial?
NCT06063681 is sponsored by Stingray Therapeutics. The principal investigator is Vinod Ganju, MD at Peninsula & South Eastern Haematology & Oncology Group. The trial plans to enroll 25 participants.