protocolSection identificationModule nctId: NCT06307795, orgStudyIdInfo id: ANS014004-I-US-01, briefTitle: A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Avistone Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors., conditionsModule conditions: Locally Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: ANS014004, outcomesModule primaryOutcomes measure: Incidence of Adverse Events (AEs), primaryOutcomes measure: Incidence of Serious Adverse Events (SAEs), primaryOutcomes measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol, primaryOutcomes measure: Incidence of baseline laboratory finding, ECG and vital signs changes, primaryOutcomes measure: Proportion of patients with radiological response (ORR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Plasma PK concentrations, secondaryOutcomes measure: Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Clearance, secondaryOutcomes measure: Pharmacokinetics of ANS014004: Half-life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sarah Cannon Research Institute, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: MD, role: CONTACT, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Advent Health, city: Orlando, state: Florida, zip: 32804, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: The University of Texas - MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: NEXT Oncology, Virginia, city: Fairfax, state: Virginia, zip: 22031, country: United States, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Univ. of Washington Medical Center, city: Seattle, state: Washington, zip: 98109-1024, country: United States, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False