protocolSection identificationModule nctId: NCT06384352, orgStudyIdInfo id: YL211-INT-101-01, briefTitle: A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2027-04-07, completionDateStruct date: 2029-04-07, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: MediLink Therapeutics (Suzhou) Co., Ltd., class: INDUSTRY, collaborators name: Hoffmann-La Roche, descriptionModule briefSummary: This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined.Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211.Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 155, type: ESTIMATED, armsInterventionsModule interventions name: YL211, outcomesModule primaryOutcomes measure: To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0, primaryOutcomes measure: To evaluate nature and frequency of DLTs in part 1., primaryOutcomes measure: ORR assessed using RECIST version 1.1, primaryOutcomes measure: To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors, secondaryOutcomes measure: To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To evaluate the anti-drug immune response after treatment with YL211, secondaryOutcomes measure: To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1, otherOutcomes measure: Characterization of genomic alterations that are predictive of response to YL211, otherOutcomes measure: The use of circulating tumor DNA (ctDNA) to monitor response to YL211 treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT San Antonio, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Site Coordinator, role: CONTACT, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False