Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer

Inclusion Criteria:

* Written informed consent
* Female or male aged \>18 years
* Clinically significant anemia of chronic disease (ACD) attributed to histologically or cytologically proven malignancy, either hematological or solid tumor, of any grade or stage: Hemoglobin (Hb) 7.0 g/dL to 10 g/dL, Transferrin saturation (TSAT) \<50%, Serum iron \<50 µg/dL (SI: \<9.0 µmol/L), AND Ferritin \>30 ng/mL (SI: \>30 µg/L)
* Previous treatment with systemic anti-cancer therapy / regimen
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
* Estimated life expectancy ≥12 weeks
* Men must agree to follow effective contraception methods during treatment and for 3 months after completion of treatment. Women of childbearing potential must agree to use two forms of effective contraception during treatment and for 3 months after completion of treatment.

Exclusion Criteria:

* Inability to personally provide written informed consent or to understand and collaborate throughout the study
* History of pure red cell aplasia, thalassemia major or sickle cell disease History of anemia unrelated to cancer \<10 g/dL within 6 months prior to screening
* Uncorrected iron deficiency
* Regular need for blood transfusions at intervals \<6 weeks
* Acute or myeloid leukemia
* Known or suspected chronic bleeding
* Tumor with gastro-intestinal involvement without negative test for fecal occult blood
* Suspected or known history of hemochromatosis
* Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C
* Impaired liver function with bilirubin ≥2.0 mg/dL (26 μmol/L), AST or ALT ≥2 times upper limit
* History or risk of significant hepatic disease, e.g. chronic alcohol abuse, hepatic steatosis, hepatic cirrhosis, or organ transplantation
* Severe renal impairment: estimated glomerular filtration rate (eGFR) \<30 mL/min (Cockcroft-Gault)
* Known central nervous system malignancy or metastasis
* Significant cardiac disease (e.g. uncontrolled hypertension: systolic blood pressure \[BP\] \>150 mmHg or diastolic BP \>100 mmHg; myocardial infarction or unstable angina pectoris) within 6 months prior to screening
* Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to first treatment) or lactation
* Previous participation in this study or treatment with an investigational agent \<21 days prior to treatment start
* Hemolysis or bleeding \>500 mL (measured or estimated) within 6 weeks prior to treatment start
* Treatment with erythropoiesis-stimulating agents (ESAs) or red blood cell (RBC) transfusions \<21 days prior to treatment start
* Cytotoxic anti-tumor treatment \<21 days prior to treatment start or planned during the anticipated study period (within 3 months from treatment start or randomization). Maintenance therapy is permitted throughout the study (e.g. lenalidomide, interferon)