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A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
Study Purpose
This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A, an ENPP1 inhibitor, administered orally as a monotherapy in subjects with solid tumors.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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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 daysTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
SR-8541A, an ENPP1 inhibitor, will be administered orally as a monotherapy to assess safety, tolerability, and pharmacokinetics (PK) in subjects with advanced/metastatic solid tumors. Subjects eligible for treatment include those whose disease is refractory to standard therapeutic options, or for which there are no standard therapeutic options available. All enrolled patients will orally administer SR-8541A daily. Treatment may continue until the subject's disease worsens or another treatment discontinuation criterion is met.
Arms
Experimental: SR-8541A Monotherapy
SR-8541A will be orally administered.
Interventions
Drug: - SR-8541A
orally administered ENPP1 inhibitor
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Site Contact
Charlotte Lemech
[email protected]
201-978-8032
Status
Not yet recruiting
Address
Monash Health
Clayton, Victoria, 3168
Site Contact
Amy Body
[email protected]
201-978-8032
Status
Recruiting
Address
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria, 3199
Site Contact
Vinod Ganju
[email protected]
201-978-8032
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