[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534922":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Chipscreen Biosciences, Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation","EXPERIMENTAL","Single ascending dose (SAD): Participants will receive CS23546 once on the first day (D1).\n\nMultiple ascending dose (MAD): Participants will receive CS23546 once daily from the 7th day (C1D1).",[13],"Drug: CS23546",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose expansion","Dose expansion is planned to begin when the recommended Phase 2 dose (RP2D) will be determined.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","CS23546","Tablets administered orally.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Huiqiang Huang, Ph.D.","Sun Yat-sen University Cancer Cancer","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Xinhao Wang","CONTACT","+86 0755-36993550","xinhwang@chipscreen.com",[37],{"facility":28,"status":38,"city":39,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Guangzhou","China","CN",{"type":43,"coordinates":44},"Point",[45,46],113.25,23.11667,{"lat":46,"lon":45},[49,51],{"name":50,"role":33,"phone":24,"phoneExt":24,"email":24},"Su Li",{"name":27,"role":29,"phone":24,"phoneExt":24,"email":24},{"type":53,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100534922","phase-1-a-study-of-cs23546-in-subjects-with-advanced-tumors-100534922",false,"NCT06245122","A Study of CS23546 in Subjects With Advanced Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CS23546 in Subjects With Advanced Tumors","Key Inclusion Criteria:\n\n1. Male or female and ≥18 years of age on day of signing informed consent.\n2. Histologically or cytologically confirmed unresectable advanced recurrent\u002Frefractory solid tumor or lymphoma that is failure or or intolerant of all standard therapy or for which no standard therapy is available.\n3. Individuals are required to provide tumor tissue samples for prospective detection of Programmed cell death 1 ligand 1 (PD-L1) expression and\u002For Microsatellite instability (MSI) \u002F the DNA mismatch repair (MMR) status. Subjects who cannot be provided during the dose escalation phase will be evaluated by the researchers and sponsors before deciding whether to enroll.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n5. Adequate organ function.\n6. Life expectancy ≥12 weeks.\n7. Dose expansion phase: Cohort 1, Subjects with urothelial carcinoma. Cohort 2, Subjects with Extranodal NK\u002FT-cell lymphoma (NKTCL). Cohort 3, Subjects with soft tissue sarcoma. Cohort 4, Subjects with PD-L1 expression positive and\u002For microsatellite-instability-high (MSI-H) \u002F mismatch-repair-deficient (dMMR) advanced solid tumors or lymphoma\n\nKey Exclusion Criteria:\n\n1. Received anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs\u002Fdevices that have not been approved for marketing within 28 days before the first medication.\n2. History of ≥ Grade 3 immune related Adverse Events (irAEs) or termination of treatment due to irAEs during prior treatment with Programmed death 1 (PD-1) \u002FPD-L1 antibody.\n3. Active autoimmune diseases present during the screening period and systemic treatment was received within 2 years before the first medication. Individuals who only require hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroids used for adrenal or pituitary insufficiency) can be enrolled.\n4. Presence of central nervous system metastasis and\u002For meningeal metastasis.\n5. Dose expansion phase: Subjects with solid tumors or lymphoma who have previously received PD-L1 inhibitors and belong to primary resistance.","ALL","18 Years",{"count":64,"type":65},156,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The primary objectives of this study are to characterize the safety and tolerability of CS23546 and to evaluate the pharmacokinetic (PK) characteristics and recommended phase 2 dose (RP2D) of CS23546 in subjects with advanced tumors.",[71],"Advanced Tumors","2026-04-03",{"date":74,"type":75},"2026-04-06","ACTUAL",{"date":77,"type":75},"2024-03-27",{"date":79,"type":65},"2027-05-31",{"name":5,"class":6},1]