[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xcovery Holdings, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100469488","phase-1-bpi-361175-tablets-in-patients-with-advanced-non-small-cell-lung-cancer-nsclc-100469488",false,"NCT05393466","BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)","A Phase I\u002FII, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Male or female ≥ 18 years old;\n2. Life expectancy ≥ 12 weeks;\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n4. Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent\u002Fmetastatic NSCLC with EGFR mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment.\n5. For dose escalation: patients with documented EGFR mutation that have progressed on or after third-generation EGFR-TKI. In addition, other lines of therapy may have been given.\n6. For dose expansion and Phase II: patients with EGFR C797S mutation confirmed prior to enrollment on tissue or blood samples with radiological documentation of disease progression from first-generation, second-generation or third-generation EGFR-TKIs. In addition, other lines of therapy may have been given;\n7. For dose expansion and Phase II, patients must have at least one measurable tumor lesion per RECIST v1.1 criteria as per Investigator's assessment;\n8. Adequate bone marrow, liver, and renal function:\n\n   * Blood: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (1500\u002Fmm3), platelets count ≥ 100 × 109\u002FL, hemoglobin ≥ 9 g\u002FdL (90 g\u002FL) (must not have received transfusion or granulocyte colony-stimulating factor within 2 weeks of screening tests and procedures);\n   * Liver function: total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN; if liver metastases exist, AST and ALT ≤ 5.0 × ULN; for patients with documented Gilbert's syndrome, total bilirubin ≤ 3.0 × ULN;\n   * Renal function: Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fmin (calculated by CKD-EPI);\n9. All acute toxic effects of any prior antitumor therapy or surgery must have resolved to baseline or ≤ CTCAE Grade 1 (with the exception of alopecia);\n10. For women with childbearing potential, serum pregnancy test will be performed within 7 days before dosing, with a negative result, and they must be non-lactating; all patients should take medically recognized contraceptive measures throughout the treatment period and 3 months after the last dose (see section Error! Reference source not found.);\n11. Men with partners of childbearing potential willing to use adequate contraceptive measures during the study and for 90 days after the last dose of study medication.\n12. Patients must have fully understood and voluntarily signed informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Presence of another active primary malignant tumors;\n2. Unstable, symptomatic primary CNS tumors\u002Fmetastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators. A patient can be enrolled if his\u002Fher clinical condition is stable and imaging evidence does not show disease progression within 2 weeks prior to the first dose, and who is off corticosteroid, anticonvulsant or mannitol treatment for longer than 2 weeks prior to the first dose.\n3. Treatment with the most recent therapy (e.g., chemotherapy, immunotherapy, targeted therapy, radiation therapy, investigational therapy\u002Fagent) within 4 weeks or approximately 5 half-lives, whichever is the longer, before the first dose. (If sufficient wash-out time has not occurred due to schedule or PK properties, an alternative appropriate wash-out time based on known duration and time to reversibility of drug related adverse events could be agreed upon by the sponsor and investigators);\n4. Gastrointestinal disorders that would affect oral swallowing or the investigators judge the absorption of the study drug will be interfered;\n5. Use of strong or moderate CYP3A inhibitors or inducers within 7 days prior to the first dose;\n6. Autologous (within 3 months) or allogeneic (within 6 months) organ or stem cell transplantation prior to the first dose; any major surgery or severe trauma (except biopsy sampling) within 4 months prior to the first dose;\n7. Palliative radiation therapy within 2 weeks prior to the first dose;\n8. Patients who have active viral hepatitis B (HBV) infection (exception: HBV DNA ≤ 500 IU\u002FmL and has been stable for longer than 4 weeks);\n9. Patients who have active infections that required systemic therapy within 1 week prior to the first dose;\n10. Any of the following cardiac conditions within the last 6 months:\n\n    Unexplained or cardiovascular cause of presyncope or syncope, tachycardia, ventricular fibrillation, or sudden cardiac arrest. Prolonged corrected QT interval \\[mean resting corrected QT interval QTcF \\> 450 msec for males or \\> 470 msec for females from 3 electrocardiogram (ECG)\\];\n11. Any \\> CTCAE Grade 1 prior to the first dose;\n12. Medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, any uncontrolled systemic disease, and other serious illnesses;\n13. Patients with deep venous thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months prior to the first dose (implantable venous access-port, catheter-related thrombosis or superficial venous thrombosis is not considered as \"serious\" thromboembolism);\n14. The presence of drug abuse and medical, psychological, or social conditions that do not permit compliance with the protocol or will not be available for protocol-required study visits or procedures.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and a Phase II component.",[27],"Non-small Cell Lung Carcinoma",[29],"non-small cell lung carcinoma","NOT_YET_RECRUITING","2025-10-06",{"date":33,"type":34},"2025-10-07","ACTUAL",{"date":36,"type":20},"2026-07-01",{"date":38,"type":20},"2029-05-31",{"name":40,"class":41},"Xcovery Holdings, Inc.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":68,"locationsCount":69},"100373755","expanded-access-to-ensartinib-for-participants-with-alk-nsclc-100373755","NCT04146571","Expanded Access to Ensartinib for Participants With ALK+ NSCLC","Expanded Access Intermediate-Size Patient Population Protocol","Inclusion Criteria:\n\n1. Adult patients (\\>18 years-of-age) with advanced ALK-positive NSCLC as determined by an FDA approved test.\n2. Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.\n3. Informed consent must be provided by each patient.\n4. Patient is not eligible or does not have access for participation in any of the other ongoing clinical trials for ensartinib.\n5. Ability to swallow and retain oral medication.\n6. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication.\n7. Adequate organ system function.\n8. Patients with treated CNS metastases are eligible if they are asymptomatic with respect to the CNS metastases and do not require escalating doses of systemic corticosteroids. ALK-positive patients with untreated CNS lesions may be allowed to enroll as long as the patients are asymptomatic with respect to the CNS metastases and do not require systemic corticosteroids or anticonvulsants.\n\nExclusion Criteria:\n\n1. Patients currently receiving cancer therapy.\n2. Use of an investigational or targeted drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of ensartinib. A minimum of 10 days between termination of the treatment and administration of ensartinib is required. However, in the case of ALK TKIs, a 2-day window between termination of the TKI and the start of ensartinib is allowed. In addition, any drug-related toxicity should have recovered to Grade 1 or less, with the exception of alopecia.\n3. Any major surgery or immunotherapy within the last 21 days (focal radiation does not require a washout period; ≥4 weeks for whole brain radiotherapy). Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.\n4. Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib (e.g., crizotinib) or to the active ingredient of ensartinib or to tartrazine, a dye used in the ensartinib 100 mg capsules.\n5. Patients receiving CYP3A substrates with narrow therapeutic indices, strong CYP3A inhibitors, and strong CYP3A inducers.\n6. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib.\n7. Clinically significant cardiovascular disease.\n8. Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have known hepatitis C, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.\n9. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n10. Have a history or the presence at baseline of pulmonary interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis.\n11. Females who are pregnant or breastfeeding.\n12. Patient with any concurrent condition or receiving any concurrent medication that, in the investigator's opinion, would impart excessive risk associated with study participation or otherwise make it inappropriate for the patient to participate.","EXPANDED_ACCESS","This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).",[52,53],"Non-Small Cell Lung Cancer","ALK Gene Rearrangement Positive",[55,56,57,58,59,60,61,52,62,63],"ensartinib","X-396","X396","anaplastic lymphoma kinase","ALK+","ALK positive","NSCLC","ALK inhibitor","carcinoma","AVAILABLE","2022-10-18",{"date":67,"type":34},"2022-10-20",{"name":40,"class":41},4,""]