[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangzhou Gloria Biosciences Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,66],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100555624","phase-3-mobilization-of-stem-cells-with-motixafortide-bl-8040-in-combination-with-g-csf-in-multiple-myeloma-patients-100555624",false,"NCT06514508","Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients","A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma","Inclusion Criteria:\n\n* (Limit: 15,000 characters)\n\n  1. Patients must have a signed study informed consent prior to entering the study.\n  2. Patients must be between the ages of 18 and 78 years.\n  3. Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria.\n  4. At least one week (7 days) from last induction cycle of combination\u002Fmulti-agent chemotherapy (e.g. KRD \\[carfilzomib, lenalidomide, dexamethasone\\] or VRD \\[bortezomib, lenalidomide, dexamethasone\\]) or from last single agent chemotherapy (e.g. lenalidomide, pomalidomide, bortezomib, dexamethasone, etc) prior to the first dose of G-CSF for mobilization.\n  5. Eligible for Autologous Hematopoietic stem cell transplantation according to the Investigator's discretion.\n  6. The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR).\n  7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n  8. Adequate organ function at screening.\n  9. Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative serum pregnancy test at screening and negative serum pregnancy test within 72 hours prior to G-CSF first administration. Women of childbearing potential (WOCBP) and male subjects with WOCBP partners must agree to use highly effective contraception method during the study period and within 90 days after the last study treatment.\n\nExclusion Criteria:\n\n1. Previous history of autologous or allogeneic-HCT.\n2. Failed previous HSC collections or collection attempts.\n3. Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period:\n\n   1. Dexamethasone: 7 days\n   2. Thalidomide: 7 days\n   3. Lenalidomide: 7 days\n   4. Pamolidomide: 7 days\n   5. Bortezomib: 7 days\n   6. Carfilzomib: 7 days\n   7. G-CSF: 14 days\n   8. GM-CSF or Neulasta®: 21 days\n   9. Erythropoietin or erythrocyte stimulating agents: 30 days\n   10. Eltrombopag, romiplostim or platelet stimulating agents: 30 days\n   11. Carmustine (BCNU): 42 days\u002F6 weeks\n   12. Daratumumab or any other anti-CD38: 28 days\n   13. Ixazomib: 7 day.\n4. Received \\>6 cycles lifetime exposure to thalidomide or lenalidomide.\n5. Received \\>8 cycles of alkylating agent combinations.\n6. Received \\> 6 cycles of melphalan.\n7. Received prior treatment with radioimmunotherapy (e.g. radionuclides).\n8. Received prior treatment with venetoclax.\n9. Plans to receive maintenance treatment within 60 days post- transplantation (e.g.lenalidomide, bortezomib, pomalidomide, thalidomide, carfilzomib, etc.).\n10. Has received a live vaccine within 30 days of the planned start of G-CSF administration. Seasonal flu vaccines that do not contain live virus are permitted.\n11. Known active CNS metastases or carcinomatous meningitis.\n12. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to motixafortide, G-CSF, or other agents used in the study.\n13. Has an active or uncontrolled infection requiring systemic therapy.\n14. Has a known additional malignancy that is progressing or requires active treatment.\n15. Is currently participating and\u002For receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n16. O2 saturation \\\u003C 92% (on room air).\n17. Personal history or family history of Long QT Syndrome or Torsade de Pointes.\n18. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden cardiac death.\n19. Myocardial infarction, CABG, coronary or cerebral artery stenting and\u002For angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months, Angina Pectoris Class \\>2 or NYHA Heart Failure Class \\>2.\n20. ECG at screening showing QTcF \\> 470 msec and\u002For PR \\> 280 msec.\n21. Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block, unless the patient has an implanted pacemaker or implantable cardiac defibrillator (ICD) with backup pacing capabilities.\n22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n23. Is pregnant or breast feeding or expecting to conceive or women of childbearing potential unless consent to use two contraceptive methods or highly effective contraception, within the projected duration of the trial, starting with the Screening Visit through 90 days after the last dose of study drug.\n24. Known human immunodeficiency virus (HIV) or active Hepatitis B (e.g., Hepatitis B Surface Antigen \\[HBsAg\\] reactive and HBV DNA\\>500 IU\u002FmL or \\>2500 copies\u002FmL) or Hepatitis C (e.g., Hepatitis C Virus \\[HCV\\] RNA \\[qualitative\\] is positive).\n25. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.","ALL","18 Years","78 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.",[27],"Multiple Myeloma","RECRUITING","2025-12-08",{"date":31,"type":32},"2025-12-16","ACTUAL",{"date":34,"type":32},"2025-12-01",{"date":36,"type":21},"2027-05-31",{"name":38,"class":39},"Guangzhou Gloria Biosciences Co., Ltd.","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100509131","phase-1-immuno-oncology-drugs-gls-012-alone--in-combination-gls-010-treating-with-advanced-patients-solid-tumors-100509131","NCT05909436","Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors","A Phase I\u002FII Study Evaluating the Safety, Tolerability and Preliminary Efficacy of GLS-012 Monotherapy and in Combination With GLS-010 in Patients With Advanced Solid Tumors After Progression on Standard Treatment (Triumph-01)","Inclusion Criteria:\n\n1. Patients who are willing to sign the informed consent form;\n2. Aged 18-75 years, male or female;\n3. Histologically confirmed diagnosis of a solid tumor;\n4. Patients with advanced solid tumors after progression on standard treatment;\n5. Subjects must have at least 1 measurable target lesion according to RECIST version 1.1；\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1；\n7. Life expectancy more than 12 weeks;\n8. Adequate organ function and bone marrow function as indicated by the screening assessments in the screening period;\n9. Women of childbearing potential must use highly effective contraception during the study period and at least 6 months after the last study drug administration, and must have a negative blood pregnancy test within 3 days before study enrollment.\n\nExclusion Criteria:\n\n1. Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of the last anti-tumor treatment have not recovered to grade ≤ 1, except for hypothyroidism\u002Fhyperthyroidism and dermatitis that have recovered to grade ≤ 2, and AEs with no safety risks judged by the investigators, for example, alopecia.\n2. Patients with primary or secondary immunodeficiency, or patients who are receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization.\n3. Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;\n4. Known central nervous system (CNS) metastases;\n5. Patients with severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies in the past.\n6. Patients with other malignant tumors within 5 years before screening, except cured cervical carcinoma in situ and cured skin basal cell carcinoma.\n7. Cardiac clinical symptoms or diseases that are not well controlled.\n8. Known hereditary or acquired bleeding and thrombosis tendency.\n9. Patients with congenital or acquired immunodeficiency disorders (such as HIV-infection), or a history of organ transplantation.\n10. Patients complying with any of hepatitis B surface antigen (HBsAg) positive and HBV-DNA copies being more than 2500 copies\u002Fml (or 500 IU\u002Fml); or positive HCV-RNA;\n11. Patients with poor compliance or other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.","75 Years",{"count":50,"type":21},107,[52,53],"PHASE1","PHASE2","This is a phase I\u002FII study to investigate the safety, tolerability, and preliminary efficacy of GLS-012 monotherapy and in combination with GLS-010 in subjects with advanced solid rumor after progression on standard treatment.",[56],"Solid Tumor","2023-06-11",{"date":59,"type":32},"2023-06-18",{"date":61,"type":32},"2022-10-31",{"date":63,"type":21},"2026-12",{"name":38,"class":39},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":73,"minAge":17,"maxAge":48,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":65},"100500635","phase-3-a-study-of-gls-010-plus-platinum-containing-chemotherapybevacizumab-as-first-line-treatment-for-persistent-recurrent-or-metastatic-cervical-cancer-100500635","NCT05798819","A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate GLS-010 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer","Inclusion Criteria:\n\n1. Signed the informed consent form.\n2. Women aged ≥ 18 and ≤ 75 years.\n3. ECOG of 0 or 1.\n4. Life expectancy ≥ 12 weeks.\n5. Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1),.The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma.\n6. No prior systemic therapy for persistent, recurrent or metastatic (\\[FIGO\\] Stage IVB) disease,not amenable to curative surgery or concurrent chemoradiotherapy.\n7. At least one measurable tumor lesion per RECIST v1.1; lesions previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.\n8. Subjects must have adequate organ function.\n9. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. Female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Patients with the opportunity to be cured by surgery and radiotherapy.\n2. Received with concurrent chemoradiotherapy, adjuvant chemotherapy,neo- adjuvant chemotherapy within 4 weeks prior to randomization.\n3. Active central nervous system (CNS) metastasis.\n4. Patients with other malignancies prior to randomization. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have been cured are not excluded.\n5. Has an active autoimmune disease that has required systemic treatment.\n6. With active serious infections.\n7. Subjects with HIV infection ,active hepatitis B virus infection, active hepatitis C virus infection,active tuberculosis infection,active syphilis .\n8. Has not recovered adequately from toxicity and\u002For complications from surgery prior to randomization.\n9. . .\n10. Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab.\n11. Have received any investigational treatment in other clinical trials within 4 weeks prior to randomization.\n12. Pregnant or lactating women,or women may become pregnant during treatment.\n13. Has had an allogeneic tissue\u002Fsolid organ\u002F hematopoietic stem cells transplant.\n14. History of nervous system and mental disease. History of drug abuse.\n15. The patient is not suitable to participate the study in the opinion of the investigator.","FEMALE",{"count":75,"type":21},424,[24],"This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.",[79],"Persistent, Recurrent, or Metastatic Cervical Cancer","NOT_YET_RECRUITING","2023-04-04",{"date":83,"type":32},"2023-04-05",{"date":85,"type":21},"2023-05-01",{"date":87,"type":21},"2026-12-01",{"name":38,"class":39},""]