SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies

Inclusion criteria

• . 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 Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 at screening;
• . Subjects with life expectancy ≥6 months as judged by the investigator on the date of first dose;
• . All male subjects and female subjects of childbearing potential who agree to use a medically acceptable method of contraception from the day of signing the ICF until 90 days after last dose of investigational product (see section 4.3 for acceptable method of contraception);
• . Subjects voluntary to participate in the trial, having signed the ICF, able to understand the procedures and methods of this trial and willing to strictly follow the clinical trial protocol to complete the trial.

Exclusion criteria