[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhejiang ACEA Pharmaceutical Co. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100482728","phase-1-safety-and-efficacy-study-of-an-anti-cd38-antibody-drug-conjugate-in-relapsed-or-refractory-multiple-myeloma-100482728",false,"NCT05565807","Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma","A Phase Ib\u002FIIa, Open-Label, Dose-Escalation and Extension Study to Evaluate the Safety and Efficacy of An Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥18 years old, regardless of gender.\n2. Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed\u002Frefractory after the most recent anti-MM therapy.\n3. Diagnosis of MM according to IMWG criteria with measurable lesions, meeting at least 1 of the following criteria:\n\n   * Serum M protein ≥ 0.5g\u002FdL (≥ 5 g\u002FL); or\n   * Urine M protein ≥ 200mg\u002F24 hours; or\n   * When the serum free light chain (FLC) ratio is abnormal, the affected FLC level is ≥10mg\u002FdL (≥100 mg\u002FL) (the normal FLC ratio is 0.26 to 1.65).\n4. ECOG performance status score is 0, 1, or 2.\n5. Willing and able to comply with the study schedule and all other study protocol requirements.\n6. Women of childbearing potential (WOCBP) (infertile women are defined as sexually mature females who had undergone a hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation\u002Fclosure, or who are infertile due to a congenital or acquired condition or spontaneously menopausal for ≥ 12 months) must have a negative blood pregnancy test during the screening. Female subjects of childbearing potential and male subjects with fertility must use a highly effective method of contraception from screening to 6 months after the last treatment.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any of the ingredients of this product.\n2. Diagnosis of active plasma cell leukemia.\n3. Diagnosis of systemic light chain amyloidosis.\n4. MM involving the central nervous system.\n5. Has POEMS syndrome.\n6. There is spinal cord compression associated with MM.\n7. Needs to take concomitant drugs with a strong inhibitory effect or a strong induction effect on CYP3A4.\n8. Had received plasma exchange therapy within 28 days before the first administration of the study drug.\n9. Had received the following anti-tumor treatments before the first administration of the study drug: monoclonal antibody or cytotoxic drug or radiotherapy within 28 days; immunoregulator, targeted therapy or epigenetic therapy or investigational medical product or invasive investigational medical device or other anti-myeloma therapy within 28 days or 5 half-lives (whichever is shorter); proteasome inhibitor or anti-tumor traditional Chinese medicine treatment or corticosteroids with a cumulative dose of more than 140 mg prednisone (or equivalent) or a single dose of more than 40 mg\u002Fday dexamethasone (or equivalent) within 14 days.\n10. Had received CAR-T therapy or allogeneic hematopoietic stem cell transplantation therapy within 6 months before the first administration of the study drug, or have a concomitant disease of active graft-versus-host disease (GvHD) at screening.\n11. Had received autologous hematopoietic stem cell transplantation within 12 weeks before the first administration of the study drug.\n12. Had undergone major surgery or eye surgery within 28 days before the first administration of the study drug.\n13. Other malignant diseases within 3 years before the first administration of the study drug.\n14. History of grade ≥3 (muscle paralysis, eyelid disease, glaucoma requiring drug control, tearing eyes), or grade ≥2 any other ocular disease (as judged by NCI-CTCAE version 5.0) at screening.\n15. Has ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain.\n16. The toxicity caused by the previous anti-tumor treatment did not subside to ≤ grade 1.\n17. Has the following hematological test results within 7 days before the first administration of the study drug:\n\n    1. Hemoglobin \\\u003C80g\u002FL\n    2. Platelet count \\\u003C50×10\\^9\u002FL\n    3. Absolute neutrophil count \\\u003C1.0×10\\^9\u002FL\n18. Has the following blood chemistry test results within 7 days before the first administration of the study drug:\n\n    1. Estimated creatinine clearance \\\u003C30mL\u002Fmin.\n    2. AST or ALT\\>3×upper limit of normal (ULN) or serum total bilirubin\\> 1.5×ULN.\n19. Severe or uncontrolled cardiovascular and cerebrovascular diseases requiring treatment, including:\n\n    1. New York Heart Association class\\>2;\n    2. Unstable angina pectoris that cannot be controlled by drugs;\n    3. Myocardial infarction occurred within 6 months before the first administration of the study drug;\n    4. Poorly controlled arrhythmias;\n    5. 12-lead ECG QTcF\\>470msec;\n    6. Left ventricular ejection fraction \\\u003C40%;\n    7. Poorly controlled hypertension ;\n    8. Stroke, cerebrovascular accident, or transient ischemic attack occurred within 6 months before the first administration of the study drug.\n20. Meets any of the following criteria:\n\n    1. Known chronic obstructive pulmonary disease (COPD) and forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal;\n    2. Known moderate or severe persistent asthma, or a history of asthma within the past 2 years, or current uncontrolled asthma of any classification;\n    3. with interstitial lung disease requiring corticosteroid therapy, drug-induced interstitial lung disease, a history of radiation pneumonitis, orclinically active interstitial lung disease suggested by any current evidence before the first administration of the study drug.\n21. Has an active bacterial, viral, or fungal infection or needs for intravenous antibiotic administration (IV) within 72 hours before the first administration of the study drug.\n22. Active or uncontrolled HBV , HCV , HIV positive.\n23. Is currently pregnant or breast feeding.\n24. Has any active severe mental illness, medical illness, or other symptoms\u002Fconditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.","ALL","18 Years",{"count":19,"type":20},84,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a phase Ib\u002FIIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma.",[27],"Relapsed or Refractory Multiple Myeloma","RECRUITING","2025-08-11",{"date":31,"type":32},"2025-08-15","ACTUAL",{"date":34,"type":32},"2023-02-09",{"date":36,"type":20},"2028-02-19",{"name":38,"class":39},"Zhejiang ACEA Pharmaceutical Co. Ltd.","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100512045","phase-1-a-study-to-evaluate-the-sti-8591-in-subjects-with-advanced-acute-myeloid-leukemia-aml-100512045","NCT05947344","A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)","A Multicenter, Open, Dose Escalation and Dose Expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\nTo be enrolled in this study, subjects must meet all of the following inclusion criteria.\n\n1. Voluntary signing of ICF.\n2. Age ≥ 18 years old.\n3. Expected survival \\>12 weeks.\n4. Dose escalation component: Advanced primary AML or myelodysplastic neoplasm (MDS) secondary to AML or MDS\u002Fmyeloproliferative neoplasm (MPN)-associated AML (AML-MR) diagnosed by 2022 WHO AML typing and with diagnostic criteria that have failed standard therapy or are intolerant of standard therapy may be considered for inclusion in this component of the study. Dose extension section: Advanced primary AML or MDS secondary to AML or AML-MR diagnosed according to the 2022 WHO AML typing and associated diagnostic criteria, who have failed or are intolerant to standard therapy, or who are unable to access standard therapy for various reasons, may only be considered for inclusion in this part of the study.\n5. ECOG scores physical fitness status 0 to 2.\n6. Subjects are willing to undergo a bone marrow aspiration\u002Fbiopsy as required by the protocol, which is used to assess the subject's response to treatment.\n7. Laboratory test index requirements within 7 days prior to the first dose, including:\n\n   White blood cell count (WBC) ≤ 20 x 109 \u002FL \\[(hydroxyurea is allowed up to the first dose to stabilize the WBC count up to a maximum dose of 5 g\u002Fday. Hydroxyurea may be continued for up to 28 days after the first dose (i.e., the first dosing cycle) at the discretion of the investigator, but generally not beyond 28 days)\\].\n\n   Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver involvement is known).\n\n   Aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if liver involvement is known) Total bilirubin (TBIL) ≤ 1.5 x ULN (\\\u003C 3.0 x ULN if diagnosed with Gilbert's syndrome) Estimated glomerular filtration rate (eGFR, calculated according to the Cockcroft-Gault formula or by measuring 24-hour urine) \\> 50 mL\u002Fmin.\n8. Residual toxicity of previous antitumor therapy ≤ grade 1 (except alopecia and hyperpigmentation; see inclusion criteria 7 for laboratory test indices)\n9. Be willing and able to comply with the study schedule and all other study protocol requirements.\n10. Women of childbearing potential (WOCBP) (women of childless potential defined as sexually mature women who have undergone hysterectomy or bilateral oophorectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation\u002Fclosure, or who are unable to have children because of congenital or acquired disease or who have been spontaneously menopausal for ≥12 months) must have a negative blood pregnancy test performed during screening.\n11. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use a highly effective method of contraception from the time of screening until 180 days after the last treatment.\n12. Subjects are required to provide FLT3 mutation status testing within 6 months prior to the first dose, and if not, are willing to undergo screening period testing as required by the protocol.\n\nExclusion Criteria:\n\nTo be enrolled in this study, subjects must not meet any of the following exclusion criteria.\n\n1. Known hypersensitivity to any component of the study drug formulation.\n2. Subjects were diagnosed with acute promyelocytic leukemia (APL).\n3. Subjects have BCR-ABL positive leukemia (chronic myelogenous leukemia acute).\n4. Subjects developed secondary AML after previous antitumor therapy for other tumors (except MDS, MDS\u002FMPN).\n5. Subjects had CNS leukemia with associated clinical symptoms.\n6. Enrolled in any therapeutic clinical study within 28 days prior to the first dose and enrolled in treatment, except in the survival follow-up phase of the interventional study.\n7. Received anti-tumor therapy (including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, etc.) within 28 days or 5 half-lives (whichever is shorter) prior to the first dose. Received radiotherapy within 14 days prior to the first dose. Palliative radiotherapy for symptom control is allowed to be completed at least 7 days prior to the first dose. Have received herbal therapy with approved indications for antitumor use within 7 days prior to the first dose.\n8. ≥ Grade 2 graft-versus-host disease (GvHD), including acute, chronic or overlapping or escalating GvHD therapy within 14 days prior to first dose or being treated with systemic cortisol hormone for GvHD.\n9. Received chimeric antigen receptor T-cell immunotherapy (CAR-T) within 3 months prior to the first dose.\n10. Strong inducer or strong inhibitor of cytochrome P450 (CYP450) 2C8 or 3A4 enzymes taken within 14 days prior to the first dose, unless the investigator assesses that the drug is necessary for the subject's treatment regimen.\n11. Major surgery within 28 days prior to first dose or minor surgery within 7 days prior to first dose, except diagnostic biopsy, insertion of vascular access device\n12. Subjects have clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and vascular hemophilia.\n13. Intractable hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and with previous recurrent episodes.\n14. Active tuberculosis, or interstitial lung disease requiring corticosteroid therapy, drug-induced interstitial lung disease, history of radiation pneumonia, or clinically active interstitial lung disease as suggested by any current evidence, prior to the first dose.\n15. Presence of an uncontrolled active infection (defined as exhibiting persistent signs\u002Fsymptoms associated with the infection that do not improve despite appropriate antibiotic or other treatment) within 72 hours prior to the first dose. Ongoing use of prophylactic antibiotics, antifungals, or antivirals is eligible for enrollment.\n16. Inability to take oral medication, history of previous surgery or severe gastrointestinal disorders such as dysphagia and active gastric ulcer, which the investigator believes may affect the absorption of the study drug.\n17. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism (other than thrombosis due to vascular access devices or superficial venous thrombosis) within 3 months prior to the first dose.\n18. Active or uncontrolled HBV (HBsAg positive and\u002For HBcAb positive with positive HBV-DNA titers), HCV (HCV-Ab positive with positive HCV-RNA titers), HIV positive.\n19. History of clinically significant cardiovascular disease, including.\n\n    1. Congestive heart failure (NYHA classification ≥ Class III) within 6 months prior to first dose\n    2. Unstable angina occurred within 6 months prior to the first dose.\n    3. Myocardial infarction within 6 months prior to the first dose.\n    4. Presence of poorly controlled arrhythmias at screening (e.g., subjects with ventricular tachycardia occurring during antiarrhythmic drug therapy will be excluded; however, subjects with atrioventricular block of degree I or asymptomatic left anterior bundle branch block\u002Fright bundle branch block do not have to be excluded).\n    5. Diagnosis or suspicion of long QT syndrome at screening (including a family history of long QT syndrome)\n    6. QTcF interval \\>450 msec (using the Fridericia formula).\n    7. Left ventricular ejection fraction (LVEF) \\\u003C45%.\n    8. Uncontrolled hypertension (on the basis of lifestyle improvement, blood pressure has not reached the standard after applying a reasonably tolerable adequate dose of 2 or more antihypertensive drugs for more than 1 month, or blood pressure can be effectively controlled only after taking 4 or more antihypertensive drugs).\n    9. Stroke, cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose.\n20. Pregnant or lactating women.\n21. Any active serious mental illness, medical condition or other symptom\u002Fcondition that, in the judgment of the investigator, may interfere with treatment, compliance or the ability to provide informed consent.",{"count":19,"type":20},[23],"This is a first-in-human, dose-escalation and dose-expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form (ICF) and have been screened for enrollment in this study.\n\n* Dose escalation phase: rapid titration and conventional 3+3 test design were used to evaluate the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and PK characteristics of STI-8591.\n* Dose Expansion Phase: Evaluate the safety, preliminary efficacy and determine the recommended phase II dose (RP2D) of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose.",[52],"AML, Adult",[54],"FLT3 inhibitor","2025-03-12",{"date":57,"type":32},"2025-03-17",{"date":59,"type":32},"2023-12-08",{"date":61,"type":20},"2025-12",{"name":38,"class":39},1,""]