A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies

Exclusion Criteria

• •Current participation in another therapeutic clinical trial
• •Prior treatment with an anti-PD-L1 or anti-PD-1 antibody
• •Patients with symptomatic central nervous system (CNS) metastases unless considered adequately treated and controlled for at least 2 weeks
• •Prior hematopoietic stem cell transplantation
• •History of other previous cancer that would interfere with the determination of safety or efficacy
• •Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for participants with vitiligo, hormone replacement therapy for stable thyroid diseases and Type 1 diabetes mellitus
• •Apparent active or latent tuberculosis (TB) infection
• •Seropositive for or have active infection with hepatitis C virus (HCV), unless HCV viral load is below the limit of quantification and participant is on concurrent viral suppressive therapy
• •Seropositive for or have active viral infection with hepatitis B virus (HBV), unless HBV viral load is below the limit of quantification and participant is on concurrent viral suppressive therapy
• •Seropositive for or active viral infection with HIV, unless the following are met:
• •* CD4+ T-cell (CD4+) counts ≥ 350 cells/uL; and
• •* Participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to screening and have HIV viral load \< 400 copies/mL; and
• •* Participant has not had acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months prior to screening
• •Active infection (viral, bacterial, or fungal) requiring intravenous (IV) systemic therapy within 14 days
• •Evidence of bleeding diathesis or coagulopathy.
• •Significant proteinuria
• •Conditions requiring chronic steroid use (\> 10 mg/day of prednisone or equivalent).
• •Recent history of attenuated viral vaccination within 30 days prior to the first dose of study intervention
• •Herbal preparations/medications are not allowed throughout the treatment period unless first discussed with and approved by the Medical Monitor
• •History of severe hypersensitivity reactions to other monoclonal antibodies or known hypersensitivity to the study intervention or its excipients.
• •Known current drug or alcohol abuse
• •Major surgical procedures ≤ 28 days prior to the first dose of study intervention, or minor surgical procedures ≤7 days prior to the first dose of study intervention
• •Pregnant or lactating
• •Any of the following cardiac diseases currently or within the last 6 months:
• •* QT interval corrected using Fridericia's formula \>450 milliseconds in men and \> 470 milliseconds in women (up to 480 milliseconds may be allowed after discussion between the Investigator and the Medical Monitor).
• •* Left Ventricular Ejection Fraction (LVEF) \<45% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
• •* Unstable angina pectoris
• •* Congestive heart failure (New York Heart Association ≥ Grade 2)
• •* Acute myocardial infarction
• •* Clinically significant conduction abnormality not controlled with pacemaker or medication
• •* Significant ventricular or supraventricular arrhythmias (Participants with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible.)
• •Underlying medical conditions that, in the opinion of the investigator and/or medical monitor, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results