Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 7:27 AM
Study NCT ID:
NCT06307795
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'From the time of first dose to 28 days post last dose of ANS014004', 'description': 'Number of patients with adverse events by system organ class and preferred term'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'From time of first dose to 28 days post last dose of ANS014004', 'description': 'Number of patients with serious adverse events by system organ class and preferred term'}, {'measure': 'Incidence of dose-limiting toxicities (DLT) as defined in the protocol', 'timeFrame': 'From time of first dose of ANS014004 to end of DLT period (approximately 30 days)', 'description': 'Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol'}, {'measure': 'Incidence of baseline laboratory finding, ECG and vital signs changes', 'timeFrame': 'From time of first dose to 28 days post last dose of ANS014004', 'description': 'measured by laboratory and vital sign variables over time including change from'}, {'measure': 'Proportion of patients with radiological response (ORR)', 'timeFrame': 'From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）', 'description': 'Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)', 'description': 'The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)', 'description': 'The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)', 'description': 'From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression'}, {'measure': 'Progression free Survival (PFS)', 'timeFrame': 'rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)', 'description': 'The time from first dose until RECIST 1.1 defined disease progression or death due to any cause'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years)', 'description': 'The time from the date of the first dose of study treatment until death due to any cause'}, {'measure': 'Pharmacokinetics of ANS014004: Plasma PK concentrations', 'timeFrame': 'From date of first dose up until 28 days post last dose', 'description': 'Measurement of plasma concentrations of ANS014004, total antibody and total unconjugated warhead'}, {'measure': 'Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC)', 'timeFrame': 'From date of first dose up until 28 days post last dose', 'description': 'Measurement of PK parameters: Area under the concentration time curve (AUC)'}, {'measure': 'Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max)', 'timeFrame': 'From date of first dose up until 28 days post last dose', 'description': 'Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)'}, {'measure': 'Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max)', 'timeFrame': 'From date of first dose up until 28 days post last dose', 'description': 'Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)'}, {'measure': 'Pharmacokinetics of ANS014004: Clearance', 'timeFrame': 'From date of first dose up until 28 days post last dose', 'description': 'Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)'}, {'measure': 'Pharmacokinetics of ANS014004: Half-life', 'timeFrame': 'From date of first dose up until 28 days post last dose', 'description': 'Measurement of PK parameters: Terminal elimination half-life (t 1/2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced or Metastatic Solid Tumors']}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Life expectancy ≥ 12 weeks\n* Measurable disease per RECIST v1.1\n* Adequate organ and marrow function as defined in the protocol\n* With a pathogenetic MET alteration (including MET mutation, MET amplification, MET overexpression, MET fusion)\n\nExclusion Criteria:\n\n* Active infection including tuberculosis and HBV, HCV or HIV\n* Known active or untreated CNS metastases\n* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression\n* Participants with serious cardiovascular or cerebrovascular diseases'}, 'identificationModule': {'nctId': 'NCT06307795', 'briefTitle': 'A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avistone Biotechnology Co., Ltd.'}, 'officialTitle': 'A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'ANS014004-I-US-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANS014004 Monotherapy', 'description': 'Part 1 aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of ANS014004.\n\nPart 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors.', 'interventionNames': ['Drug: ANS014004']}], 'interventions': [{'name': 'ANS014004', 'type': 'DRUG', 'description': 'Varying doses of ANS014004', 'armGroupLabels': ['ANS014004 Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advent Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Resarch Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NEXT Oncology, Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Avistone Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@avistonebio.com', 'phone': '8610 84148921'}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Avistone Biotechnology Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avistone Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}