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
Stingray Therapeutics
25 participants
Oct 12, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- Histopathologically/cytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options.
- Measurable disease per RECIST v1.1
- Willing to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
- Adequate hematologic, renal and hepatic function
Exclusion Criteria18
- Primary central nervous system (CNS) tumor
- Prior systemic anti-cancer treatment including other investigational agents, surgery, or radiation within 28 days or 5 half-lives, whichever is less
- Continuous systemic treatment with either corticosteroids (>10 milligram \[mg\] daily prednisone equivalents) or other immunosuppressive medications within 28 days
- Active autoimmune disease that has required systemic treatment in past 2 years
- 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
- Troponin I > ULN
- Blood pressure (BP) - Systolic < 95 mmHg or > 160 mmHg or diastolic > 100 mmHg
- Resting heart rate (HR) > 100 beats per minute (BPM)
- Corrected QT interval by Fridericia (QTcF) ≥ 470 ms
- Left Ventricular Ejection Fraction (LVEF) < 50%
- Symptomatic uncontrolled CNS disease requiring treatment with steroids or anti-seizure medications within 2 months
- Leptomeningeal disease
- 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
- Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment
- Prior additional malignancy that is progressing or has received treatment the previous 3 years
- Active infection requiring systemic treatment
- 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
- Major surgery within 28 days prior to Day 1 and/or minor surgery (excluding biopsy) within 7 days
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Interventions
orally administered ENPP1 inhibitor
The ICI will be either nivolumab or pembrolizumab.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06063681