[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xynomic Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100460419","phase-1-xp-102-and-xp-102-in-combination-with-trametinib-in-advanced-solid-tumor-patients-with-a-braf-v600-mutation-100460419",false,"NCT05275374","XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation","A Dose-escalation and Expansion Phase I\u002FIIa Study of XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation (ENHANCE)","ENHANCE","Inclusion Criteria:\n\n* ≥18 years of age\n* Advanced malignant solid tumor patients with a BRAF V600 mutation (limited to melanoma, colorectal cancer, non-small cell lung cancer, or thyroid cancer).\n* Must have failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Prior treatment with BRAF inhibitors and\u002For MEK inhibitors is permitted；\n* At least one measurable lesion (brain metastasis must not be the only measurable lesion) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1);\n* ECOG performance status of 0 or 1;\n* Expected survival ≥ 3 months;\n* Adequate liver, renal, coagulation, cardiac, and hematologic function.\n* A negative pregnancy test if female patient is of reproductive potential.\n* For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study.\n* Patients must agree to, and be capable of, adhering to the study visit schedule and all other protocol requirements;\n* Patients must understand and voluntarily sign the written informed consent form, before the initiation of any study-specific procedures in the trial.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) lesions. However, patients with asymptomatic and brain metastases who received treatment (including targeted brain radiotherapy, surgical treatment, glucocorticoid or other treatments) without disease progression for ≥ 3 months are eligible.\n* Patients who received radiotherapy, immunotherapy, hormone therapy, targeted therapy, biotherapy, traditional Chinese medicine therapy, chemotherapy or any clinical trial treatment within 14 days before the first dose.\n* Patients who have persistent toxicity caused by previous chemotherapeutic drugs or radiotherapy has not recovered to lower than grade 2 (except hair loss) according to CTCAE version 5.0;\n* Patients who are allergic to active substances or excipients of XP-102 or trametinib.\n* Significant traumatic injury within 28 days before the first dose of the investigational drug, or if major surgery is anticipated during the course of study treatment;\n* According to the judgment of the investigator, patients with dysphagia, or any gastrointestinal diseases that may affect drug absorption or activity;\n* Administration of strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 14 days before the first dose of the investigational drug;\n* Patients who are receiving drugs that may prolong QT interval and unable or unwilling to stop treatment or switch to other alternative treatment before study enrollment;\n* Symptomatic active fungal, bacterial and\u002For viral infections; including known HIV, active hepatitis B, active hepatitis C or active syphilis infection.\n* Any poorly controlled disorders (such as serious mental, neurological, cardiovascular, respiratory, digestive, urinary, bleeding and coagulation, or other system diseases) that may significantly affect the clinical trial;\n* Other situations not suitable for participation in the study as judged by the investigator.","ALL","18 Years",{"count":20,"type":21},221,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a first-in-human multi-center study which will be conducted in advanced malignant solid tumors patients. The solid tumor type is limited to melanoma, colorectal, non-small-cell lung, and thyroid cancer with positive BRAF V600 mutation. This study is divided into three stages: Phase Ia: a dose-escalation phase of XP-102; Phase Ib: a dose-escalation and sample size expansion phase of XP-102 plus trametinib; Phase IIa: an expansion phase of XP-102 plus trametinib.",[28,29,30,31,32,33],"Cancer","BRAF V600 Mutation","Melanoma","Colorectal Cancer","Thyroid Cancer","Nonsmall Cell Lung Cancer","NOT_YET_RECRUITING","2025-04-09",{"date":37,"type":38},"2025-04-10","ACTUAL",{"date":40,"type":21},"2025-12-31",{"date":42,"type":21},"2028-12-30",{"name":44,"class":45},"Xynomic Pharmaceuticals, Inc.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100357600","phase-2-study-to-evaluate-efficacy-and-safety-of-oral-abexinostat-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-dlbcl-100357600","NCT03936153","Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Abexinostat as Monotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL);\n2. Have received only two prior standard therapy lines for diffuse large B-cell lymphoma (DLBCL) including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy;\n3. Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;\n4. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;\n6. Meet various hematological, liver and renal function lab parameters.\n\nExclusion Criteria:\n\n1. Have primary central nervous system (CNS) lymphoma or secondary central nervous system (CNS) infiltration, transformed lymphoma, unclassified B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (HL), primary effusion lymphoma, plasma lymphoma;\n2. Toxicity not yet recovered from previous anti-tumor therapies;\n3. Uncontrolled systemic infections or infections requiring intravenous antibiotics;\n4. Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;\n5. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;\n6. Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;\n7. Presence of active graft-versus-host reaction;\n8. Have undergone a major surgery within the last month;\n9. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;\n10. Have any cardiac impairment as defined per protocol;\n11. Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).",{"count":54,"type":21},170,[25],"An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)",[58],"Diffuse Large B-cell Lymphoma (DLBCL)","RECRUITING",{"date":37,"type":38},{"date":62,"type":38},"2020-01-20",{"date":64,"type":21},"2027-08-31",{"name":44,"class":45},23,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100331224","phase-3-a-study-of-pazopanib-with-or-without-abexinostat-in-patients-with-locally-advanced-or-metastatic-renal-cell-carcinoma-renaviv-100331224","NCT03592472","A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)","A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)","Inclusion Criteria:\n\nTo be enrolled in the study, patients will be required to meet all of the following criteria:\n\n* Patients aged ≥ 18 years at time of study entry.\n* Patients have histologically confirmed RCC with clear cell component.\n* Patients have locally advanced and unresectable or metastatic disease.\n* Measurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.\n* Patients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced\u002Fmetastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.\n* Patients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Patients have adequate baseline organ function.\n* Patients have adequate baseline hematologic function\n* Patient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria at Screening will not be enrolled in the study:\n\n* Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5 from previous anticancer therapy (excluding alopecia which is permitted and excluding Grades 2 and 3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies).\n* Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or progressive metastases obtained at least 4 weeks following completion of treatment. CNS imaging during Screening is not required unless clinically indicated.\n* Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, and non-muscle invasive urothelial carcinoma.\n* Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted.\n* A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization.\n* Has a QTcF interval \\> 480 msec.\n* New York Heart Association Class III or IV congestive heart failure.\n* Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.",{"count":75,"type":21},413,[77],"PHASE3","This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).",[80],"Renal Cell Carcinoma",[80,82,83,84,85,86],"Progression-free survival","Abexinostat","Pazopanib","RECIST","Cancer therapy",{"date":88,"type":38},"2025-04-13",{"date":90,"type":38},"2018-07-17",{"date":92,"type":21},"2028-06-30",{"name":44,"class":45},38,""]