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)
Parallel
SAL-0951 tablets 4mg
Druginitial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
SAL-0951 tablets 5mg
Druginitial phase：5mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
Incidence of Adverse events by CTCAE5.0
laboratory abnormalities (based on whole blood count, biochemistry, coagulation function, fecal occult blood test and urinalysis tests), vital sign measurements (include blood pressure, pulse rate and body-temperature), physical examination-and-12-Lead electrocardiogram.
Change from baseline in mean Hb at the end of treatment (EOT);
through study completion, an average of 4 months, the change from baseline in mean Hb at the end of treatment
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