Phase
Condition
Neoplasms
Treatment
Immune checkpoint inhibitor (ICI)
SR-8541A
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
Histopathologically/cytologically confirmed advanced solid tumor, which isrefractory to standard therapeutic options, or for which there are no standardtherapeutic options.
Measurable disease per RECIST v1.1
Willing to provide archival or fresh tumor tissue during screening (required) andpost-treatment (optional)
Adequate hematologic, renal and hepatic function
Exclusion
Exclusion Criteria:
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] dailyprednisone 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; clinicallysignificant valvular heart disease; high-risk uncontrolled arrhythmias (includingsustained ventricular tachycardia); myocardial infarction, unstable angina,cerebrovascular accident, or transient ischemic attack within the last 6 months, orCanadian 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 oranti-seizure medications within 2 months
Leptomeningeal disease
Spinal cord compression not definitively treated with surgery and/or radiation orpreviously diagnosed and treated spinal cord compression without evidence thatdisease has been clinically stable for at least 8 weeks
Bleeding diathesis due to underlying medical condition or anticoagulation medicationwhich is unable to be promptly reversed by medical treatment
Prior additional malignancy that is progressing or has received treatment theprevious 3 years
Active infection requiring systemic treatment
Positive for human immunodeficiency virus (HIV) (HIV antibodies) or active hepatitisB (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
Study Design
Study Description
Connect with a study center
Scientia Clinical Research Ltd
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria 3168
AustraliaActive - Recruiting
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria 3199
AustraliaActive - Recruiting
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