[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479828":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":43,"locations":44,"responsibleParty":65,"collaborators":43,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":43,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":43,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":43,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Jiangsu Simcere Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation","EXPERIMENTAL","Participants will receive SCR-6920 capsule orally at escalating doses, till the maximum tolerated dose level is reached, and the recommended phase 2 dose(RP2D) will be determined.",[13],"Drug: SCR-6920 capsule",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose expansion: non small cell lung cancer(NSCLC)","Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose expansion: NHL","Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis",[13],{"label":23,"type":10,"description":20,"interventionNames":24},"Dose expansion: solid tumors",[13],[26,33,37,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","SCR-6920 capsule","SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis",[9],[32],"PRMT5 inhibitor",{"type":27,"name":28,"description":34,"armGroupLabels":35,"otherNames":36},"SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis",[15],[32],{"type":27,"name":28,"description":34,"armGroupLabels":38,"otherNames":39},[19],[32],{"type":27,"name":28,"description":34,"armGroupLabels":41,"otherNames":42},[23],[32],null,[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Shandong Cancer Hospital","RECRUITING","Jinan","Shandong","250117","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.99722,36.66833,{"lat":57,"lon":56},[60],{"name":61,"role":62,"phone":63,"phoneExt":43,"email":64},"Jinming Yu","CONTACT","0531-67626971","sdyujinming@126.com",{"type":66,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100479828","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-scr-6920-capsule-in-patients-with-advanced-malignant-tumors-100479828",false,"NCT05528055","A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors","A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed NHL\n* Relapsed\u002Frefractory solid tumor or relapsed\u002Frefractory NHL who have progressed during or after standard therapy or for which treatment is not tolerated, not suitable, not available.\n* At least one evaluable or measurable lesion (as defined in the protocol).\n* ECOG Performance Status 0 or 1.\n* Life expectancy ≥12 weeks.\n* Adequate organ function (as defined in the protocol).\n* Reproductive criteria (as defined in the protocol).\n\nExclusion Criteria:\n\n* Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption.\n* Major surgery, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. Radiation therapy within 2 weeks prior to study entry.\n* Adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by chemotherapy have recovered to ≤ grade 2 ).\n* Autologous hematopoietic stem cell transplantation was performed within 9 months prior to the first dose.\n* History of a second malignancy within 2 years (as defined in the protocol).\n* Active uncontrolled or symptomatic lung disease (as defined in the protocol).\n* Intracranial hypertension or active uncontrolled or symptomatic CNS metastases.\n* Known or suspected hypersensitivity to study medications.\n* Known active uncontrolled or symptomatic CNS metastases.\n* The investigator determined that the patient should not participate in the study.\n* Known mental illness or substance abuse that may disrupt therapy.\n* Clinically significant cardiac abnormalities (as defined in the protocol).\n* Gestating or Lactating women.\n* Pleural effusion, pericardial effusion or ascites that need diuretics or draining within 2 weeks prior to first dose.\n* The patient is currently using a drug known to be a strong inhibitor or inducer of CYP3A4.","ALL","18 Years","75 Years",{"count":78,"type":79},122,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","A Phase 1, open label, multi center, dose escalation and expansion study will assess the safety, tolerability, PK, and preliminary efficacy of SCR-6920 capsule in participants with advanced malignant tumors. The purpose of the study is to identify the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D), and to confirm the tolerability and preliminary efficacy of SCR-6920 in participants with advanced solid tumors and relapsed\u002Frefractory non-Hodgkin lymphoma(NHL).",[85,86],"Solid Tumor","Non Hodgkin Lymphoma","2022-09-02",{"date":89,"type":90},"2022-09-06","ACTUAL",{"date":92,"type":90},"2022-05-18",{"date":94,"type":79},"2027-10",{"name":5,"class":6},1]