Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-28 @ 2:11 PM
Study NCT ID:
NCT04555304
Status:
UNKNOWN
Last Update Posted:
2020-09-18
First Post:
2020-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527363', 'term': 'KH902 fusion protein'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival（PFS）', 'timeFrame': 'Time from date of randomization until the date of first documented Progression or date of death from any cause， whichever came frist，assessed up to18 months', 'description': 'Date of randomization until the date of first documented Progression or date of death from any cause， whichever came first'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Time from date of randomization until the date of first documented CR or PR，assessed up to18 months', 'description': 'Percentage of Participants with a Best Overall Response (BOR) of Partial Response (PR) or Complete Response (CR)'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Time from first documented evidence of CR or PR until the date of first documented progression ，assessed up to18 months', 'description': 'is defined as the time from first documented evidence of CR or PR until the date of first documented progression as assessed by RECIST 1.1 or death; assessed up to18 months'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Time from date of randomization until the date of first documented Progression，assessed up to18 months', 'description': 'Percentage of Participants who have achieved CR, PR and SD to study treatment;'}, {'measure': 'AE', 'timeFrame': 'AEs（NCI CTCAE 5.0） collected at each cycle，Assessed up to18 months', 'description': 'Number of Subjects with treatment-related adverse events (AEs)Defined by all'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Gastroesophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of the study drug known as KH903 in participants with gastric and gastroesophageal cance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Prior to any detailed procedures of this study, subjects are able to understand, voluntarily participate in and sign the informed consent approved by the ethics committee.\n* 2.Age ≥ 18 years.\n* 3.Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma .\n* 4.Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.\n* 5.Have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum or/and fluoropyrimidine doublet for unresectable or metastatic disease.Second line chemotherapy is suitable for paclitaxel.\n* 6.Laboratory test values must meet the following criteria. ANC ≥1.5×109/L, platelets ≥ 100×109/L, hemoglobin≥9g/dL. Blood creatinine ≤ 1.5 ×ULN or creatinine clearance ≥ 50 mL/min/m2. Total bilirubin ≤ 1.5× ULN(≤ 3 x ULN if Gilbert disease), AST and ALT ≤ 2.5× ULN (≤ 5×ULN if hepatic metastasis).\n\nINR ≤ 1.5× ULN, APTT ≤ 1.5× ULN. Dipstick proteinuria \\<2+ or 24 hour proteinuria \\<1g .\n\n* 7.Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1.\n* 8.Life expectancy of ≥ 3 months.\n\nExclusion Criteria:\n\n* 1.Histologically confirmed squamous cell carcinoma or undifferentiated gastric cancer.\n* 2.Patients with disease progression within 6 months after previous adjuvant or neoadjuvant chemotherapy with paclitaxel, or patients with recurrent or metastatic gastric adenocarcinoma or GEJ adenocarcinoma treated with paclitaxel.\n* 3\\. GI perforation and/or fistulae in the 6 months preceding randomization.\n* 4.Deep-vein thrombosis, pulmonary embolism (PE), or any other episode of Uncontrolled thromboembolism in the 6 months preceding randomization.\n* 5.Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack)\n* 6.Uncontrolled hypertension (≥150/100 mm Hg ) despite properly observed antihypertensive therapy.\n* 7.Known brain metastasis.\n* 8.Known allergy to paclitaxel or KH903.\n* 9.Serious concurrent infection or medical illness.\n* 10.Active hepatitis B virus or Active hepatitis C virus (HCV) infection at screening.\n* 11.Any condition which results in an undue risk for the patient during the trial participation according to the investigator.'}, 'identificationModule': {'nctId': 'NCT04555304', 'briefTitle': 'Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kanghong Biotech Co., Ltd.'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of Weekly Paclitaxel With or Without KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine', 'orgStudyIdInfo': {'id': 'KH903-40101-CRP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KH903 + Paclitaxel', 'description': 'IV KH903 4 mg/kg IV paclitaxel 80 mg/m²', 'interventionNames': ['Drug: KH903 + Paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Paclitaxel', 'description': 'IV Placebo IV paclitaxel 80 mg/m²', 'interventionNames': ['Drug: Placebo + Paclitaxel']}], 'interventions': [{'name': 'KH903 + Paclitaxel', 'type': 'DRUG', 'description': 'KH903 4 mg/kg will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle； Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle', 'armGroupLabels': ['KH903 + Paclitaxel']}, {'name': 'Placebo + Paclitaxel', 'type': 'DRUG', 'description': 'Placebo will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle； Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle', 'armGroupLabels': ['Placebo + Paclitaxel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'yi ba, PhD', 'role': 'CONTACT', 'email': 'bayi@timuch.com', 'phone': '13752157916'}], 'overallOfficials': [{'name': 'yi ba, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Kanghong Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}