SystImmune Inc.
The objective of the study is to evaluate the safety and tolerability of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.
This study is an open-label, multicenter, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary efficacy of SI-B036 in participants with locally advanced or metastatic solid tumors.
Inclusion Criteria: * Documented locally advanced or metastatic solid tumor(s) not amenable to curative surgery or radiation and have received at least 1 line of standard therapy, including adjuvant/neoadjuvant treatment, or whose cancer is considered refractory to the standard of care (SOC) or for which no standard treatment is available. * Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V6.0. * Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%. *…
SI-B036 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks