[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kind Pharmaceuticals LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":166},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,65,87,108,128,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100630442","phase-3-a-study-of-and017-to-evaluate-efficacy-and-safety-in-patients-with-anemia-due-to-non-dialysis-dependent-chronic-kidney-disease-ndd-ckd-100630442",false,"NCT07487727","A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)","A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients","Key Inclusion Criteria:\n\n* A diagnosis of CKD confirmed at screening, KDOQI CKD stage 3, 4, or 5 defined by estimated Glomerular Filtration Rate (eGFR) using the CKD Epidemiology Collaboration (EPI) formula.\n* Not on dialysis and no clinical evidence of impending need to initiate dialysis during the study treatment.\n* Prior ESA and hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment\n\n  1. ESA\u002FHIF-PHI-naïve: Defined as no use of any ESA\u002FHIF-PHI treatment for at least 12 weeks before randomization; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be ≥7.5 g\u002FdL and \\\u003C10.0 g\u002FdL with a difference of ≤1.3 g\u002FdL between the two values;\n  2. ESA-treated: Defined as having received an approved ESA, administered intravenously or subcutaneously, for at least 6 weeks prior to randomization, with no change in ESA product and no treatment interruption exceeding 2 consecutive weeks; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be 9.0-12.0 g\u002FdL inclusive.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3× upper limit of normal (ULN)\n* Transferrin saturation (TSAT) ≥20% or ferritin ≥100 ng\u002FmL at screening test\n* Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test\n\nKey Exclusion Criteria:\n\n* Concurrent retinal neovascular lesions requiring treatment.\n* Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms.\n* History of gastric\u002Fintestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment.\n* Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure \\>180 mmHg, or diastolic blood pressure \\>110 mmHg during the screening assessment\n* Concurrent congestive heart failure (New York Heart Association \\[NYHA\\] Class III or higher).\n* History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.\n* Participants with a history of significant liver disease or active liver disease.\n* History of a seizure disorder or any occurrence of seizures in the past.\n* Serum albumin (ALB) \\\u003C 2.5 g\u002FdL at screening test.\n* Prior ESA\u002FHIF-PHI treatment caused total bilirubin \\>1.5xULN, or AST\u002FALT\u002FALP\\>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.).\n* Any prior functioning organ transplant or a scheduled organ transplantation, or anephric.","ALL","18 Years","75 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in non-dialysis-dependent (NDD)-CKD patients compared with the active control, ESA treatment",[27],"Anemia Due to Chronic Kidney Disease",[29,30],"anemia","CKD","RECRUITING","2026-03-24",{"date":34,"type":35},"2026-03-27","ACTUAL",{"date":37,"type":35},"2025-12-03",{"date":39,"type":21},"2027-07-01",{"name":41,"class":42},"Kind Pharmaceuticals LLC","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100630956","phase-3-a-study-of-and017-to-evaluate-efficacy-and-safety-in-dialysis-dependent-chronic-kidney-disease-dd-ckd-patients-with-anemia-100630956","NCT07494409","A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia","A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia","Key Inclusion Criteria:\n\n* Receiving stable hemodialysis (including combination methods such as hemodiafiltration or hemofiltration), peritoneal dialysis for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription.\n* Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks\n* The mean of two hemoglobin values during screening must be 9.0-12.0 g\u002FdL.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\\\u003C3× upper limit of normal (ULN)\n* Transferrin saturation ≥20% or ferritin ≥100 ng\u002FmL at screening test\n* Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test\n\nKey Exclusion Criteria:\n\n* Concurrent retinal neovascular lesions requiring treatment\n* Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms\n* History of gastric\u002Fintestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment\n* Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure \\>180 mmHg, or diastolic blood pressure \\>110 mmHg during the screening assessment\n* Concurrent congestive heart failure (New York Heart Association \\[NYHA\\] Class III or higher)\n* History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment\n* Participants with a history of significant liver disease or active liver disease\n* History of a seizure disorder or any occurrence of seizures in the past\n* Serum albumin (ALB) \\\u003C 2.5 g\u002FdL at screening test\n* Prior ESA\u002Fhypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment caused total bilirubin \\>1.5xULN, or AST\u002FALT\u002F ALP\\>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.)\n* Any prior functioning organ transplant or a scheduled organ transplantation, or anephric",{"count":52,"type":21},300,[24],"This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)",[27],[29,30,57],"ESKD","2026-03-20",{"date":34,"type":35},{"date":61,"type":35},"2025-10-31",{"date":63,"type":21},"2027-04-30",{"name":41,"class":42},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":43},"100539458","phase-2-a-study-of-efficacy-and-safety-of-and017-in-patients-with-myelodysplastic-syndrome-100539458","NCT06304103","A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome","An Efficacy and Safety Study of AND017 for the Treatment of Anemia Due to Lower Risk Myelodysplastic Syndromes (MDS)","Inclusion Criteria:\n\n1. Diagnosed of primary myelodysplastic syndrome with a PISS-R grading of very low, low or intermediate risk and a bone marrow primitive cell count \\\u003C 5%, the time frame for this grading assessment should be at least 12 weeks prior to the first dose\n2. Non-5q(del)-associated myelodysplastic syndrome.\n3. Two non-transfused hemoglobin ≥ 6.0 g\u002FdL and \\\u003C 10.0 g\u002FdL, averaged over the screening period, at least one week and more apart, and with no more than 1.3 g\u002FdL difference between the two Hb.\n4. Non-transfused subjects (NTD cohort) defined as no red blood cell transfusion in the 16 weeks prior to randomization or low transfusion load subjects defined as 3-7 pRBC units transfused in the 16 weeks prior to randomization and at least two different time points (LTB-1 cohort) or 1-2 pRBC units transfused at one time point in the 16 weeks prior to randomization ( LTB-2 cohort) (except in the case of transfusion for treatment of other comorbidities such as blood loss, surgery, etc.);\n5. Baseline EPO level ≤ 500 mU\u002FmL\n6. Platelets ≥ 30,000 \u002Fmm3 and absolute neutrophil count ≥ 800\u002Fmm3\n7. Adequate liver function with:\n\n   * Total bilirubin \\\u003C2 x upper limit of normal (ULN) (subjects with Gilbert's syndrome, i.e., unconjugated hyperbilirubinemia, have a total bilirubin \\\u003C3 x ULN)\n   * Aspartate aminotransferase (AST) \\\u003C3 x ULN\n   * Alanine aminotransferase (ALT) \\\u003C3×ULN\n\nExclusion Criteria:\n\n1. Diagnosed of secondary myelodysplastic syndrome or concurrent anemia from a cause other than the primary myelodysplastic syndrome.\n2. Significant myelofibrosis (fibrosis ≥ 2+).\n3. Planned clearing chemotherapy or whole brain spinal cord radiotherapy during the study period.\n4. Previous diagnosis of MDS IPSS-R high or very high risk.\n5. Prior or planned hematopoietic stem cell transplant during the study period.\n6. Received granulocyte colony-stimulating factor (G-CSF), or thrombopoietin, or thrombopoietin receptor agonist therapy within 8 weeks prior to the first dose;\n7. Treatment with antithymocyte globulin, azacitidine, decitabine, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to the first dose.\n8. The presence of active infection or inflammatory disease requiring systemic anti-infective therapy, including concomitant autoimmune disease with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)\n9. Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.)\n10. Inability to take oral medications, or a history of gastrectomy, concomitant gastroparesis, or other conditions that may have an impact on the absorption of gastrointestinal medications (excluding gastric polyps or colonic polypectomy)\n11. Clinically significant bleeding (including transfusions required to treat bleeding or bleeding resulting in a decrease in hemoglobin ≥ 2 g\u002FdL) within 4 weeks prior to the first dose, or a bleeding constitutional or bleeding risk that has not been medically or surgically corrected.\n12. Uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values ≥ 100 mmHg and\u002For systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing)\n13. Comorbid heart failure (New York Heart Association \\[NYHA\\] class III or higher)\n14. Medical history of significant liver disease or active liver disease at screening assessment\n15. Have been treated with any other hypoxia-inducing factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to the first dose\n16. Have been treated with an erythropoietic ESA within 8 weeks prior to the first dose\n17. Have been treated with an androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 8 weeks prior to the first dose\n18. Have been treated with an iron chelator within 8 weeks prior to the first dose",{"count":73,"type":21},63,[75],"PHASE2","This is a Phase 2, multicenter, randomized, open-lable, dose ranging study to evaluate the efficacy and safety of AND017 for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS) in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB).",[78],"Myelodysplastic Syndromes","2026-02-25",{"date":81,"type":35},"2026-02-27",{"date":83,"type":35},"2025-03-14",{"date":85,"type":21},"2027-05",{"name":41,"class":42},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100539334","phase-2-a-study-of-safety-and-efficiency-of-and017-in-patients-with--thalassemia-100539334","NCT06302491","A Study of Safety and Efficiency of AND017 in Patients With β-thalassemia","A Study of Safety and Efficiency of AND017 in Patients With Transfusion Dependent and Non-transfusion Dependent β-thalassemia","Inclusion Criteria:\n\n1. Documented diagnosis of β-thalassemia or hemoglobin E\u002Fβ-thalassemia, HbS\u002F β-thalassemia (β-thalassemia with α-bead mutation and\u002For multiplication is not allowed).\n2. TDT subjects: receive regular blood transfusions, defined as 6-20 RBC units (including threshold) in the 24 weeks prior to screening assessment, and no transfusion-free period of ≥ 5 weeks during this period.\n3. NTDT cohort: having transfused \\\u003C6 RBC units in the 24 weeks prior to the screening assessment, no regular transfusion schedule, and no transfusion for 4 weeks prior to the screening assessment.\n4. Subject transfusion records should be obtained within 24 weeks prior to the screening assessment, containing the date of transfusion, transfused RBC units, and pre-transfusion hemoglobin values.\n5. ECOG score 0-1.\n6. NTDT subjects with Hb ≤ 10.0 g\u002FdL at screening test and one follow-up test (two tests more than one week apart) and difference in values between the two tests ≤ 1.0 g\u002FdL.\n7. Adequate liver function: Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) (subjects with Gilbert syndrome, i.e., unconjugated hyperbilirubinemia, have a total bilirubin \\\u003C 3 x ULN), aspartate aminotransferase\n\nExclusion Criteria:\n\n1. Other causes of anemia (e.g., hemolytic anemia, history of pure red blood cell aplastic anemia, myelodysplastic syndrome, or multiple myeloma)\n2. Presence of active infection or inflammatory disease requiring systemic anti-infective therapy, including concomitant autoimmune diseases with inflammatory symptoms (e.g. generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, etc.)\n3. Complicated retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.)\n4. Inability to take oral medications, conditions with a history of gastrectomy\u002Fbowel resection that may have an effect on the absorption of gastrointestinal medications (excluding gastric polyps or colonic polypectomy), or gastroparesis that remains symptomatic on current therapy\n5. Clinically significant bleeding (requiring emergency blood transfusion within 12 h or a decrease in hemoglobin ≥ 2 g\u002FdL within one week) within 4 weeks prior to the first dose, or a tendency to bleed or risk of bleeding that has not been medically or surgically corrected\n6. Uncontrolled hypertension, defined as a diastolic blood pressure value \\>95 mmHg or a systolic blood pressure \\>160 mmHg on 2 or more of 3 repeated blood pressure tests (each at least 5 minutes apart) during the screening period\n7. Complicated congestive heart failure (New York Heart Association \\[NYHA\\] class III or higher).\n8. history of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or pulmonary infarction within 24 weeks prior to screening evaluation\n9. history of significant coagulation abnormalities, or platelet count \\>600 x 109\u002FL or \\\u003C80 x 109\u002FL\n10. History of epilepsy or any past seizures.","65 Years",{"count":96,"type":21},64,[75],"This is a phase II, randomized, double-blinded, placebo-controlled study to treat patients with transfusion-dependent and non-transfusion dependent β -thalassemia with AND017 and optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice.",[100],"β -Thalassemia",{"date":81,"type":35},{"date":103,"type":35},"2024-05-27",{"date":105,"type":21},"2027-07",{"name":41,"class":42},5,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100521857","phase-2-a-study-of-and017-to-treat-cancer-related-anemia-in-patients-not-receiving-chemotherapy-100521857","NCT06075043","A Study of AND017 to Treat Cancer Related Anemia in Patients Not Receiving Chemotherapy","A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Anemia of Cancer in Patients Not Receiving Chemotherapy","Main Inclusion Criteria:\n\n1. Non-myeloid malignancy diagnosed by cytology\u002Fhistology.\n2. ECOG score 0-2 and expected survival of 6 months or more.\n3. The mean value of hemoglobin at screening test and one follow-up test (more than one week between tests) was \\\u003C10.0 g\u002FdL, with a difference of ≤1.0 g\u002FdL between the two tests.\n4. Adequate hepatic and renal function.\n\n   * Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN).\n   * Subjects with Gilbert's syndrome (unconjugated hyperbilirubinemia) have a total bilirubin \\\u003C 3 x ULN.\n   * Aspartate aminotransferase (AST)\n   * Alanine aminotransferase (ALT) \\\u003C2.5 x ULN\n   * eGFR \\>60 mL\u002Fmin\u002F1.73\n\nExclusion Criteria:\n\n1. Received chemotherapy, radiotherapy, and other, e.g., immunosuppressive, targeted drug therapy that has a suppressive effect on the bone marrow within 1 month prior to randomization or planned during the trial.\n2. A medical history of significant liver disease or active liver disease.\n3. A previous history of pure red blood cell remittance\n4. A combination of hereditary anemia, iron-granulocytic anemia, acute blood loss, active bleeding (three consecutive positive fecal occult bloods or clinical judgment of the investigator), hemolysis and other conditions that can cause anemia such as iron, folic acid or vitamin B12 deficiency\n5. Active infection or inflammatory disease requiring systemic anti-infective therapy within 1 week prior to the first dose, including concurrent autoimmune diseases with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)\n6. Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.).\n7. clinically significant bleeding (including the need for blood transfusion or a drop in hemoglobin ≥ 2 g\u002FdL) within 4 weeks prior to the first dose, or a bleeding constitutional or bleeding risk that has not been medically or surgically corrected\n8. uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values \\> 90 mmHg and\u002For systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing)\n9. concurrent congestive heart failure (New York Heart Association \\[NYHA\\] class III or higher)\n10. clinically significant ECG abnormalities at screening assessment.\n11. Have been treated with any hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to randomization\n12. have received treatment with an erythropoietic agent, androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 6 weeks prior to screening assessment.\n13. a history of significant medical or major surgical procedure within 3 months prior to the screening assessment or elective surgery planned during the conduct of the study.",{"count":116,"type":21},36,[75],"The purpose of this study is to determine the safety and efficacy of various doses of AND017 after 6 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.",[120],"Cancer-Related Anemia","NOT_YET_RECRUITING",{"date":81,"type":35},{"date":124,"type":21},"2027-12",{"date":126,"type":21},"2028-08",{"name":41,"class":42},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100521856","phase-2-a-study-of-and017-in-cancer-related-anemic-patients-receiving-chemotherapy-100521856","NCT06075030","A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy","A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Cancer-Related Anemia Patients Receiving Chemotherapy","Inclusion Criteria:\n\n1. Non-myeloid malignancy diagnosed by cytology\u002Fhistology\n2. Receiving and have received at least one cycle of drug therapy with a high myelosuppressive adverse effect, including but not limited to chemotherapeutic agents such as platinum, targeted agents, antibody-coupled drugs, immunosuppressive agents, etc., and are expected to continue such therapy within 8 weeks of enrollment\n3. ECOG score of 0-2 and an expected survival of 6 months or more.\n4. Mean hemoglobin \\\u003C10.0 g\u002FdL at screening test and one follow-up test (at least one week thereafter during the screening period), with a difference between the two tests of ≤1.0 g\u002FdL\n5. Total bilirubin \\\u003C1.5 x upper limit of normal (ULN) If Gilbert's syndrome (unconjugated hyperbilirubinemia) have a total bilirubin \\\u003C 3 x ULN.\n6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 x ULN.\n7. No iron deficiency, TSAT ≥ 20% and ferritin ≥ 100 ng\u002FmL at screening.\n8. Serum folate and vitamin B12 ≥ lower limit of normal at screening.\n9. eGFR \\>60 mL\u002Fmin\u002F1.73 at screening.\n\nExclusion Criteria:\n\n1. Hematocrit (Hct) ≥ 36 vol% at the screening assessment.\n2. Prior history of leukemia.\n3. Extensive bone metastases from breast cancer, head and neck cancer with combined whole blood (trilineage) cytopenia, bone marrow invasion from lymphoma, definite brain metastases (except for those whose symptoms have been controlled for ≥4 weeks) or bone marrow metastases.\n4. Combination of hereditary anemia, iron-granulocytic anemia, acute blood loss, active bleeding (three consecutive positive fecal occult bloods or clinical judgment of the investigator), hemolysis and other diseases that can cause anemia such as iron, folic acid or vitamin B12 deficiency.\n5. Active infection or inflammatory disease requiring systemic anti-infective therapy within 1 week prior to the first dose, including concurrent autoimmune diseases with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)\n6. Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.)\n7. Difficulty to take oral medications, or conditions that may have an impact on the absorption of gastrointestinal medications such as a history of gastrectomy\u002Fbowel resection or concomitant gastroparesis (excluding gastric polyps or colonic polypectomy).\n8. clinically significant bleeding (including the need for blood transfusion or a decrease in hemoglobin ≥ 2 g\u002FdL) within 4 weeks prior to the first dose, or a bleeding constitutional or bleeding risk that has not been medically or surgically corrected.\n9. Uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values \\> 90 mmHg and\u002For systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing)\n10. Concurrent congestive heart failure (New York Heart Association \\[NYHA\\] class III or higher).\n11. Clinically significant ECG abnormalities at the time of screening evaluation\n12. Medical history of significant liver disease or active liver disease\n13. History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or pulmonary infarction within 24 weeks prior to the screening evaluation\n14. History of prior thrombosis, significant coagulation abnormalities, history of hematologic disease, or history of ineffective erythropoietin therapy\n15. History of epilepsy or any past seizures.\n16. Positive hepatitis B surface antigen (HBsAg), or positive anti-hepatitis C virus (HCV) antibodies, or positive human immunodeficiency virus HIV at screening evaluation.",{"count":116,"type":21},[75],"The purpose of this study is to determine the safety and efficacy of AND017 after 6 weeks of treatment in patients with cancer-related anemia who are receiving chemotherapy.",[139],"Chemotherapy Induced Anemia",{"date":81,"type":35},{"date":124,"type":21},{"date":143,"type":21},"2028-05",{"name":41,"class":42},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":152,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":43},"100453691","phase-1-a-study-of-and019-in-women-with-er-positive-her2-negative-advanced-or-metastatic-breast-cancer-100453691","NCT05187832","A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer","A Phase I Dose Escalation and Dose Expansion Study of AND019 in Patients With Estrogen Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Advanced or Metastatic Breast Cancer","Key Inclusion Criteria:\n\n1. Postmenopausal women defined as NCCN guideline at the time of informed consent.\n2. Histological or cytological confirmation of advanced or metastatic ER+\u002FHER2- breast cancer women who failed standard therapy or for which no standard therapy exists.\n3. Prior therapy:\n\n   1. No more than 1 line of chemotherapy for advanced breast cancer\n   2. Recurrence or progression on at least one line of endocrine therapy in the advanced or metastatic disease setting and derived a clinical benefit from the endocrine therapy: Recurred or progressed while being treated with adjuvant endocrine therapy for a duration of at least 24 months, or progressed under endocrine therapy for more than 6 months in the advanced or metastatic setting\n4. ECOG score 0-1.\n5. Minimum life expectancy of a least 3 months as determined by the Investigator.\n6. Evaluable disease per RECIST 1.1; for patients consent to tissue biopsy, disease suitable for tumor biopsy.\n7. Sufficient bone marrow reserve and organ function.\n\nKey Exclusion Criteria:\n\n1. Previous treatment with any SERDs.\n2. Patient any central nervous system metastasis.\n3. Prior antitumor therapies:\n\n   1. Received chemotherapies within 3 weeks before the first dose.\n   2. Received systemic radiotherapy within 3 weeks before the first dose, or local radiotherapy within 7 days before the first dose\n   3. Received other anti-tumor therapy such as endocrine therapy, immunotherapy, and target therapy within 3 weeks or 5 half-lives of the drug before the first dose of the study drug\n   4. For bone metastasis, bisphosphonates and local remission therapy are allowed (7 days washout for local radiation therapy).\n4. Patient who has participated in any other clinical trials for drugs or treatments within 5 half-lives for a prior investigational drug or 2 weeks from use of an investigational device prior to the first dose of study drug.\n5. Patient who had major surgery or significant trauma within 4 weeks prior to the first dose of study drug (excluding needle biopsy), or has scheduled surgery during the study period.\n6. Patient with serous unhealable wounds\u002Fulcers\u002Ffractures within 4 weeks prior to the first dose of study drug.\n7. Patient with adverse reactions to previous anti-tumor treatments who have not yet recovered to grade ≤1 according to CTCAE v5.0. (except for toxicities without safety risks as judged by Investigator, such as alopecia, grade 2 peripheral neuropathy etc.)\n8. Patient who has used strong inhibitors or strong inducers of CYP3A, or grapefruit or grapefruit juice within 4 weeks prior to the first dose of study drug.\n9. Patient unable to be administered oral medications or any condition that seriously affect digestion in the gastrointestinal tract at the judgement of the Investigator.\n10. Patient with active infection within 1 week prior to the first dose of study drug, and currently need systemic anti-infective treatment.\n11. Patient has a known history of the following: HIV infection without effective antiretroviral therapy (ART) or acceptable immune function, or syphilis infection, or HBsAg positive HBV or needs prophylaxis therapy or suppressive antiviral therapy before dosing, or has an HCV infection that hasn't completed curative antiviral treatment or with unacceptable viral load.\n12. Patient has active cardiac disease or a history cardiac dysfunction.\n13. Patient with third spacing that cannot be controlled clinically and is not suitable for the study by the Investigator's judgment.\n14. Patient with known history of drug abuse.\n15. Patient with mental disorder that, in the opinion of the Investigator, could lead to poor compliance with required study procedures.\n16. Patient that cannot tolerate venous blood sampling.\n17. Known to have other malignancy within the past 5 years, and is progressing or requires active treatment (except skin basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ who have received potentially radical treatment)","FEMALE",{"count":154,"type":21},61,[156],"PHASE1","This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \\[HER2\\]-negative) breast cancer.",[159],"Advanced or Metastatic Breast Cancer",{"date":81,"type":35},{"date":162,"type":35},"2022-10-05",{"date":164,"type":21},"2026-11",{"name":41,"class":42},""]