The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies
Subjects with body weight ≥40 kg at screening;
Subjects with histologically or cytologically confirmed diagnosis of non-myeloid malignancy (non-curative), and planned to receive anti-tumor treatment (myelosuppressive chemotherapy) for at least 6 weeks simultaneously from the day of the first dose (Day 1);
Subjects with myelosuppressive chemotherapy-related anemia, defined as central laboratory Hb ≤100 g/L during the screening period, and documented decrease in Hb level ≥10 g/L after the start of chemotherapy as judged by the investigator;
Subjects with ferritin ≥50 ng/mL and transferrin saturation (TSAT) ≥10% at screening;
Subjects with tumor who are receiving myelosuppressive chemotherapy and whose expected outcome is cured;
Subjects who receive hormonal agents, biologics, novel immunosuppressants (e.g., PD-1 and PD-L1 immune checkpoint inhibitors) or targeted biologic therapy or radiation therapy alone to treat/control their tumors. However, if chemotherapy is used in combination with these drugs, subjects can be enrolled;
Subjects who have received blood transfusion therapy containing red blood cells or ESAs (including but not limited to recombinant human erythropoietin, darbepoetin alfa, methoxy polyethylene glycol-epoetin beta/CERA, pegmolesatide) within 4 weeks before the first dose of investigational product;
Patients with alanine transaminase (ALT) >3×upper limit of normal (ULN), or aspartate transaminase (AST) >3×ULN, or total bilirubin (TBL) >1.5×ULN are not allowed to be enrolled in the study (those with TBL ≤2×ULN can be included if ALT/AST is within the normal limit and the investigator believes that there is no safety concern)