Clinical trial · Interventional
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced / Metastatic Solid Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune checkpoint inhibitor (ICI) | Drug | Immune Checkpoint Inhibitor | ALIAS |
| SR-8541A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SR-8541A Monotherapy
- description
- SR-8541A will be orally administered.
- interventionNames
- Drug: SR-8541A
- Drug: Immune checkpoint inhibitor (ICI)
Primary outcomes (2)
- measure
- Frequency and severity of Adverse Events
- timeFrame
- From first dose of study drug through 30 days following the last dose of study treatment
- description
- Adverse events will be graded according to CTCAE v5.0.
- measure
- Recommended Phase 2 Dose (RP2D) of SR-8541A
- timeFrame
- From first dose of study drug through 28 days following the first dose of study treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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