This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1106 in participants with advanced solid tumors.
Able and willing to provide written informed consent and to comply with the study protocol;
Subject with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC;
At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1;
Able to provide the most recent archival tumor tissue samples (negotiable);
Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention;
Participants with any infection requiring intravenous therapy, or any other uncontrolled active infection, within 2 weeks prior to informed consent;
Participants with symptomatic radiation pneumonia, radiation esophagitis, radiation colitis; extensive interstitial lung disease of both lungs, chronic obstructive pulmonary disease requiring bronchodilators or regular hormonal therapy; unhealed peptic ulcers, cirrhosis and related complications, chronic enteritis, necrotizing enteritis, gastrointestinal obstruction (except those who are relieved with treatment and have no safety risk as assessed by the investigator), gastrointestinal bleeding tendency or high risk of perforation, pancreatitis requiring treatment; arteriovenous thrombotic disease; chronic nephritis and nephrotic syndrome, within 8 weeks prior to C1D1;
Participants with active autoimmune disease or the risk of recurrence;
Single group
BA1106
DrugIn part A, after the observation period of DLT (28 days), intravenous (IV) once every 3 weeks (Q3W). In Part B, intravenous (IV) once every 3 weeks (Q3W) or once every 2 weeks (Q2W).
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
Area under the curve (AUC) of BA1106
Half-life (t1/2) of BA1106
Maximum Concentration (Cmax) of BA1106
Minimum Concentration (Cmin) of BA1106
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