[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626392":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":30,"armGroups":39,"interventions":46,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":54,"collaborators":30,"id":56,"slug":30,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":30,"enrollmentInfo":64,"targetDuration":30,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":30,"overallStatus":77,"whyStopped":30,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":30},{"fullName":5,"class":6},"Betta Pharmaceuticals Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":30},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"DLT","Number of Participants with Dose-Limiting Toxicity (DLT)AEs, including incidence and severity of findings in laboratory values and vital signs","up to 2 tears",{"measure":14,"description":15,"timeFrame":12},"RP2D","Determination of RP2D in the expansion phase",{"measure":17,"description":18,"timeFrame":19},"ORR","Further expand the inclusion to clarify the efficacy endpoint ORR","up to 3 tears",[21,25,28],{"measure":22,"description":23,"timeFrame":24},"Cmax","Maximum Observed Blood Concentration (Cmax) of BPI-572270","up to 15 weeks",{"measure":26,"description":27,"timeFrame":24},"AUC","Area Under Blood Concentration Time Curve (AUC) of BPI-572270",{"measure":29,"description":30,"timeFrame":31},"Disease Control Rate (DCR)",null,"up to 3 years",{"allocation":33,"interventionModel":34,"interventionModelDescription":30,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE","This is a Phase 1\u002F2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of BPI-572270 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and\u002For recommended phase 2 dose \\[RP2D\\] within investigated patient population groups, and to further expand the enrollment of more patients to evaluate the efficacy endpoints (ORR\u002FDCR\u002FDOR\u002FTTR).",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"Study BPI-572270 in adults with specific RAS mutant advanced solid tumors","EXPERIMENTAL","Capsules; Administer once a day on an empty stomach.",[45],"Drug: BPI-572270",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","BPI-572270","Oral Tablets",[41],[53],"BPI-572270 Capsule",{"type":55,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100626392",false,"NCT07435038","Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS.","Inclusion Criteria:\n\n* Histologically confirmed advanced solid tumor with RAS mutations identified through deoxyribonucleic acid (DNA) sequencing.\n* Have received prior standard therapy appropriate for tumor type and stage.\n* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function.\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors active and untreated brain metastases.\n* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication.\n* History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and\u002For impact their ability to comply with the protocol prior\u002Fconcomitant therapy","ALL","18 Years",{"count":65,"type":66},120,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.",[73,74,75,76],"Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Advanced Solid Tumors","NOT_YET_RECRUITING","2026-03-08",{"date":80,"type":81},"2026-03-11","ACTUAL",{"date":83,"type":66},"2026-02-12",{"date":85,"type":66},"2029-10-28",{"name":5,"class":6}]