[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chugai Pharmaceutical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":156},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,39,64,92,114,135],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100638512","phase-1-aqua07-in-patients-with-alk-positive-non-small-cell-lung-cancer-100638512",false,"NCT07617337","AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer","A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form\n* Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.)\n* Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Ability and willingness to take oral medication(s)\n* Adequate organ function and bone marrow reserve\n\nExclusion Criteria:\n\n* Prior toxicities from anti-cancer therapy which have not resolved to Grade ≤ 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy\n* Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy.\n* Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease\n* Significant cardiovascular disease\n* Inadequately controlled hypertension","ALL","18 Years",{"count":19,"type":20},102,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of AQUA07 when administered as single agent and in combination with lorlatinib in patients with ALK positive non-small cell lung cancer.",[26],"ALK Positive Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2026-05-24",{"date":30,"type":31},"2026-06-01","ACTUAL",{"date":33,"type":20},"2026-07-31",{"date":35,"type":20},"2030-08-31",{"name":37,"class":38},"Chugai Pharmaceutical","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100611342","phase-2-study-of-donq52-in-active-celiac-disease-100611342","NCT07239336","Study of DONQ52 in Active Celiac Disease","A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate The Efficacy and Safety of DONQ52 in Active Celiac Disease Patients Who Have Duodenal Mucosal Damage and Persistent Symptoms Despite Attempting A Gluten-free Diet (DAISY STUDY)","Inclusion Criteria:\n\n* Body mass index (BMI) of 18 to 40 (kg\u002Fm2) at screening.\n* Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol.\n* History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD\n* Attempting a GFD for at least 12 months prior to the screening visit.\n\n  \\- The participants should be instructed not to alter dietary habits including a GFD during the study period.\n* Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1\\*05 and HLA-DQB1\\*02) (homozygous or heterozygous).\n* Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening.\n* Willingness to undergo 2 on-study upper gastrointestinal endoscopies with duodenal biopsies.\n* Presence of ongoing duodenal mucosal damage defined as Vh:Cd of 2.5 or less\n\nExclusion Criteria:\n\n* Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator.\n* History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin).\n* History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever.\n* History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.\n* Participants who carry the HLA-DQ8 (HLA-DQA1\\*03 and DQB1\\*0302) genotype (homozygous or heterozygous).\n* Any other chronic, active gastrointestinal disease (e.g., inflammatory bowel disease, microscopic colitis, eosinophilic esophagitis, peptic ulcer, gastroesophageal reflux disease, functional dyspepsia, or irritable bowel syndrome) that might in the investigator's opinion, interfere with the assessment of GI symptoms or small intestinal histology.\n* Helicobacter pylori tests that indicate current infection.\n* Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening.\n* Positive hepatitis B surface antigen (HBsAg) test or total hepatitis B core (HBc) antibody test at screening.\n* Positive hepatitis C virus (HCV) antibody test at screening, except in participants who have negative results for HCV ribonucleic acid (RNA) test at screening.\n* Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.","75 Years",{"count":48,"type":20},92,[50],"PHASE2","The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.",[53],"Celiac Disease","RECRUITING","2026-05-19",{"date":57,"type":31},"2026-05-20",{"date":59,"type":31},"2025-12-16",{"date":61,"type":20},"2027-12-15",{"name":37,"class":38},56,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100544632","phase-1-phase-1b-trial-of-ray121-in-immunological-diseases-rainbow-trial-100544632","NCT06371417","Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)","Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Age \\>= 18 and \\\u003C=75 at the time of signing informed consent form (except for BP; Age \\>=18 and \\\u003C= 85 with Karnofsky score \\>= 60% at screening)\n3. Ability to comply with the study protocol\n4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods\n5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n6. APS cohort: Established primary APS defined by the following criteria (at least one of the laboratory criteria and one of the clinical criteria must be met):\n\n   * Laboratory criteria (aPL profile)\n\n     * Persistently positive lupus anticoagulant (LA) test\n     * Persistently positive anticardiolipin (aCL) immunoglobulin G (IgG) isotype\n     * Persistently positive anti-beta-2 glycoprotein-1 (aβ2GPI) IgG isotype\n   * Clinical criteria\n\n     * Livedoid vasculopathy and presence of skin ulcer\n     * Acute\u002Fchronic aPL nephropathy\n7. BP cohort:\n\n   * 1\\) Age \\>= 18 and \\\u003C= 85 with Karnofsky score \\>= 60 %\n   * 2\\) Predominant cutaneous lesions\n   * 3\\) Diagnosis with BP with following assessments positive:\n   * a Positive direct immunofluorescence, and either\n   * b Positive indirect immunofluorescence, or\n   * c Positive serology on ELISA for BP180 autoantibody\n   * 4\\) Bullous Pemphigoid Disease Area Index (BPDAI) score \\>= 20\n   * 5\\) Weekly average of daily Peak Pruritus Numerical Rating Score (PP-NRS) \\>=4\n   * 6\\) Accept to take photograph of bullous lesions\n8. BS cohort:\n\n   * 1\\) Diagnosed with BS\n   * 2\\) Oral ulcers that occurred at least 3 times in the previous 12 month period\n   * 3\\) Have at least 2 oral ulcers over the 4 weeks prior to screening\n   * 4\\) Have at least 2 oral ulcers at Week 0\n   * 5\\) Have prior treatment with at least 1 non-biologic BS therapy\n   * 6\\) Patients who need systemic therapy as whose oral or mucocutaneous ulcers cannot be adequately controlled by topical therapy\n9. DM cohort:\n\n   * 1\\) Diagnosed with definite or probable inflammatory myopathies and categorized as DM\n   * 2\\) Patients with inadequate response to corticosteroids and\u002For immune-suppressants or intolerance to DM therapies\n   * 3\\) Manual Muscle Test-8 (MMT-8) score \\\u003C 142, with at least one abnormality in the following Core Set Measures:\n\n     * Patient Global Activity Visual Analogue Scale (PtGA-VAS) \\>= 2 cm\n     * Physician Global Activity Visual Analogue Scale (PhGA-VAS) \\>= 2 cm\n     * Global extra-muscular activity \\>= 2 cm\n     * At least one muscle enzyme \\> 1.5 times upper limit of normal (ULN)\n     * Health Assessment Questionnaire (HAQ) \\>= 0.25\n   * 4\\) Moderate to severe DM defined as CDASI activity score \\> 14\n10. IMNM cohort:\n\n    * 1\\) Clinically Diagnosed with IMNM as anti-HMGCR myopathy or anti-SRP myopathy\n    * 2\\) Creatine kinase (CK) \\> 1,000 U\u002FL\n    * 3\\) Patients who have an inadequate response to corticosteroids and\u002For immunosuppressants or intolerance to IMNM therapies\n    * 4\\) MMT-8 score \\\u003C 142\n11. ITP cohort:\n\n    * 1\\) Confirmed diagnosis of persistent\u002Fchronic ITP based on the following criteria:\n\n      * ITP defined per the current guidelines\n      * Platelet count \\\u003C= 30 × 10\\^9\u002FL on 2 consecutive occasions\n    * 2\\) Lack of an sustained adequate platelet count response to a thrombopoietin receptor agonist and at least one other ITP treatment or a second thrombopoietin receptor agonist (TPO-RA)\n    * 3\\) A history of response with an platelet counts increase more than 20 × 10\\^9\u002FL from baseline by at least one prior line of therapy\n\nExclusion Criteria:\n\n1. History of anaphylaxis or hypersensitivity to a biologic agent\n2. Active infection requiring systemic antiviral, antibiotics or antifungal\n3. Planned surgery during the study\n4. Pregnant or breastfeeding, or intending to become pregnant\n5. Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study\n6. Clinically significant ECG abnormalities\n7. Illicit drug or alcohol abuse\n8. Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjögren's syndrome in DM and IMNM)\n9. Positive for hepatitis B surface antigen\n10. Positive for hepatitis C virus antibody\n11. Positive for human immunodeficiency virus antibody\n12. Evidence of current infection with tuberculosis\n13. History of cancer within 5 years\n14. Treatment with investigational therapy within 28 days or 5 half-lives\n15. Previous and current treatment with anti-C1s antibody at any time\n16. Other complement inhibitors within 3 months\n17. Patients who receive any treatments which fall into the Prohibited Therapy Criteria\n18. Patients with an elevated alanine aminotransferase or aspartate aminotransferase \\> 1.5 × ULN in combination with an elevated total bilirubin \\> 1.5 × ULN\n19. APS cohort:\n\n    * 1\\) APS associated with other systemic autoimmune disease\n    * 2\\) Acute thrombosis (arterial or venous acute thrombosis diagnosis) within 30 days before screening\n    * 3\\) Patients with thrombotic APS without any anticoagulation treatment\n    * 4\\) Treatment with prohibited medications\n20. BP cohort:\n\n    * 1\\) Initiation of treatment with or increase in the dose of systemic or topical corticosteroid within 2 weeks\n    * 2\\) Current treatment with a drug that may cause or exacerbate BP unless the dose has been stable\n    * 3\\) Initiation of treatment with topical calcineurin inhibitor, or topical phosphodiesterase (PDE) 4 inhibitor within 7 days\n    * 4\\) Treatment with prohibited medications\n21. BS cohort:\n\n    * 1\\) BS-related active major organ involvement-ocular lesions requiring immunosuppressive therapy, pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis), gastrointestinal (e.g., ulcers along the gastrointestinal tract), and central nervous systems (e.g., meningoencephalitis) manifestations\n    * 2\\) History of venous or arterial thrombosis within 1 year\n    * 3\\) Treatment with prohibited medications\n22. DM cohort:\n\n    * 1\\) PhGA-VAS improvement \\>= 3, or clinically relevant improvement between screening and baseline\n    * 2\\) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, IMNM, juvenile DM or drug-induced myopathy\n    * 3\\) Cancer-associated myositis\n    * 4\\) Significant muscle damage\n    * 5\\) Past history of severe Interstitial lung disease flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease\n    * 6\\) Severe respiratory muscle weakness\n    * 7\\) Severe bulbar palsy\n    * 8\\) Treatment with prohibited medications\n23. IMNM cohort:\n\n    * 1\\) PhGA-VAS improvement \\>= 3, or clinically relevant improvement between screening and baseline\n    * 2\\) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, juvenile DM or druginduced myopathy\n    * 3\\) Cancer-associated myositis\n    * 4\\) Significant muscle damage\n    * 5\\) Past history of severe Interstitial lung disease (ILD) flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease\n    * 6\\) Severe respiratory muscle weakness\n    * 7\\) Severe bulbar palsy\n    * 8\\) Treatment with prohibited medications\n24. ITP cohort:\n\n    * 1\\) Secondary ITP\n    * 2\\) Clinical diagnosis or history of Myelodysplastic Syndrome or autoimmune hemolytic anemia\n    * 3\\) History of venous or arterial thrombosis within 12 months\n    * 4\\) Patients who experienced major bleeding within 4 weeks\n    * 5\\) Treatment with prohibited medications\n    * 6\\) Any laboratory test results meet either of the following criteria at screening:\n\n      * Hemoglobin \\\u003C10 g\u002FdL\n      * Thyroid-stimulating hormone \\>= 10 μIU\u002FmL","85 Years",{"count":73,"type":20},144,[23],"This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).",[77,78,79,80,81,82],"Antiphospholipid Syndrome (APS)","Bullous Pemphigoid (BP)","Behçet's Syndrome (BS)","Dermatomyositis (DM)","Immune-mediated Necrotizing Myopathy (IMNM)","Immune Thrombocytopenia (ITP)","2026-04-01",{"date":85,"type":31},"2026-04-02",{"date":87,"type":31},"2024-08-19",{"date":89,"type":20},"2026-06-30",{"name":37,"class":38},69,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100595323","phase-1-study-of-aube00-in-patients-with-solid-tumors-100595323","NCT07030959","Study of AUBE00 in Patients With Solid Tumors","A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years at time of signing Informed Consent Form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patients with Kirsten rat sarcoma (KRAS) alteration confirmed by local tests or central laboratory test (Details are defined for each part)\n* Refractory or resistant to standard therapies or standard therapies are not available\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study or within 27 weeks after the last dose of AUBE00 or within 2 months after the last dose of cetuximab, whichever is longer.\n* Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)\n* Significant cardiovascular disease, such as New York Heart Association (NYHA) Class II or greater cardiac disease, unstable angina, or myocardial infraction within the previous 6 months or unstable arrhythmias within the previous 3 months\n* Patient with complications from a cerebrovascular disorder (such as subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, etc.) or a history of such complications within 6 months prior to enrollment",{"count":100,"type":20},130,[23],"This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors.The total number of patients in this study will be approximately 90 to 130.",[104],"Solid Tumors","2026-02-23",{"date":107,"type":31},"2026-02-25",{"date":109,"type":31},"2025-06-05",{"date":111,"type":20},"2029-12-31",{"name":37,"class":38},4,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":5},"100601207","phase-1-a-phase-i-study-of-alps12-in-patients-with-extensive-stage-small-cell-lung-cancer-100601207","NCT07107490","A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Aged \\>18 years at time of informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Histologically documented extensive stage small cell lung cancer\n* Disease recurrence documented after at least one prior systemic therapy.\n* Confirmed availability of representative archival tumor specimens or fresh tumor specimen.\n* Measurable disease per RECIST v.1.1.\n* Adequate hematologic and end organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study\n* History or complication of clinically significant autoimmune disease\n* a positive HIV antibody test at screening\n* Active hepatitis B or hepatitis C\n* Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and\u002For DLL3-targeted therapies\n* Patients who have received any investigational or approved anticancer therapy, including hormone therapy and\u002For radiotherapy, within 21 days prior to the first administration of the investigational drug.\n* History of Grade 4 immune-related adverse events caused by prior anti-PD-L1\u002FPD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase\u002Flipase)\n* Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1\u002FPD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase\u002Flipase), and\u002For patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug\n* Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug\n* History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease\n* Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)",{"count":122,"type":20},122,[23],"This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.",[126],"Extensive Stage Small Cell Lung Cancer","2026-02-04",{"date":129,"type":31},"2026-02-06",{"date":131,"type":31},"2025-10-08",{"date":133,"type":20},"2028-09-30",{"name":37,"class":38},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":113},"100509019","phase-1-a-phase-i-study-of-rose12-alone-and-in-combination-with-other-anti-tumor-agents-in-patients-with-solid-tumors-100509019","NCT05907980","A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors","A Phase Ia\u002FIb Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of ROSE12 as a Single Agent and in Combination With Other Anti-tumor Agents in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Age \\>= 18 years at time of signing informed consent form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1\n* Adequate hematologic and end-organ function\n* Life expectancy \\>= 12 weeks\n* Patients with histologic documentation of locally advanced, or metastatic solid tumor\n* \\[Dose-escalation Parts and Biopsy Parts\\]Refractory or resistant to standard therapies or standard therapies are not available\n* \\[Dose-escalation Parts and Expansion Part\\] Patients with confirmed availability of fresh tumor or representative tumor specimens\n* \\[Biopsy Parts\\] Patients with accessible lesion(s)\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular or liver disease\n* Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug\n* Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).\n* All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy\n* Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Active or history of clinically significant autoimmune disease\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n\n\\[Expansion Part\\]\n\n* Prior treatment with investigational product which has MoA of Treg depletion\n* Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1",{"count":143,"type":20},219,[23],"This is a Phase Ia\u002FIb open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.",[147],"Solid Tumor","2025-03-04",{"date":150,"type":31},"2025-03-06",{"date":152,"type":31},"2023-05-24",{"date":154,"type":20},"2026-12-31",{"name":37,"class":38},""]