protocolSection identificationModule nctId: NCT06328439, orgStudyIdInfo id: ANS014004-I-CN-01, briefTitle: A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Avistone Biotechnology Co., Ltd., class: INDUSTRY, collaborators name: Shanghai Chest Hospital, collaborators name: Hunan Cancer Hospital, collaborators name: Henan Cancer Hospital, collaborators name: Zhejiang Cancer Hospital, collaborators name: Peking University Cancer Hospital & Institute, descriptionModule briefSummary: Brief Summary: This is a Phase I, first-in-human, open-label, multi-center study designed to explore the safety, tolerability, PK, and anti-tumor antitumor activity of ANS014004 monotherapy in subjects with locally advanced or metastatic solid tumors.* The study consists of two parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). For each subject, the study will consist of a screening period (Day -28 to Day -1), a treatment period (until discontinuation of treatment) and a follow-up period (including safety follow-up and survival follow-up).* During the Treatment Period, subjects will receive ANS014004 single-agent oral administration until the subject meets any treatment termination criteria.  1, The dose-escalation part (Part 1) will consist of a single-dose period and a multiple-dose period (28 days per cycle), participants during dose escalation will receive a single dose of ANS014004 on Day 1 of the single-dose period in order to obtain complete PK parameters for the single dose. There will be a 7-day washout period between the single dosing period and the multiple dosing period at the same dose level. If no dose-limiting toxicity (DLT) occurs during the 7-day washout period, participants will begin Cycle 1 (28 days per cycle) multiple dosing treatment on Day 8, receiving ANS014004 once daily (QD). participants in the backfill cohort will enter the multiple dosing period directly. The specific dose which participant receives will depend on the different cohort assignments. The dose-escalation part (Part 1) will use the initial accelerated titration design (ATD) and the traditional "3 + 3" design to determine the MTD of ANS014004 in subjects with locally advanced or metastatic solid tumors.  2. In the Dose Expansion (Part 2), participants, will receive oral administration of ANS014004 QD at each treatment cycle (28 days per cycle). An end-of-treatment (EOT) visit will be conducted within 7 days of the final dose or investigator decision to discontinue.All subjects will undergo imaging evaluations of their tumors every 8 weeks until disease progression is confirmed by the investigator, the subject begins new antitumor therapy, dies, is lost to follow-up, or withdraws from the study, whichever occurs first., conditionsModule conditions: Locally Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Cohort1: 7.5mg Cohort2: 15mg Cohort3: 30mg Cohort4: 45mg Cohort5: 60mg, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 216, 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: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Shun Lu, Ph.D, role: CONTACT, phone: +8618017321551, email: shunlu_shchest@sina.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False