Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT04725994
Status:
RECRUITING
Last Update Posted:
2024-09-27
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'through study completion (Up to 12 months)', 'description': 'To determine the MTD and RP2D of IDX-1197 when given in combination with XELOX or Irinotecan. This will be accomplished by the standard 3+3 dose escalation design. If 2 of the 3 to 6 patients in a particular dose level experience a DLT, the dose escalation should be stopped at this dose level, and the MTD will be determined.'}, {'measure': 'Dose Limiting Toxicities (DLTs)', 'timeFrame': 'during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2', 'description': 'Occurrence of DLTs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['1197', 'IDX-1197', 'venadaparib'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach.\n* Group 2, patients with recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach, who were treated ≥2 times with palliative chemotherapy before screening.\n* At least 1 evaluable lesion for the dose escalation part and at least 1 measurable lesion according to RECIST v1.1 for the dose expansion part.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system or uncontrolled brain metastasis\n* Carcinomatous meningitis or its history.\n* For Group 1, patients who are HER 2 positive.\n* Any other concurrent uncontrolled illness including, but not limited to, active or ongoing symptomatic infection requiring IV antibiotic treatment, uncontrolled diabetes, hepatic, renal, or respiratory illness.\n* Severe or unstable angina, myocardial infarction or ischemia, symptomatic congestive heart failure, arterial or venous thromboembolism requiring coronary artery bypass graft or stent within the past 6 months or clinically significant cardiac dysrhythmia or New York Heart Association class II \\~ IV heart disease within 6 months of randomization.\n* Uncontrolled hypertension\n* Immunocompromised patients, such as patients known to be serologically positive for HIV.\n* Patients with known active Hepatitis B or C infection.\n* Patients with known active or symptomatic pneumonitis, or history of non-infectious pneumonitis requiring steroids.\n* Diagnosis of a myelodysplastic syndrome/acute myeloid leukemia or its suspicious characteristics.\n* Any unresolved clinically significant Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 toxicity\n* Resting ECG with measurable QTcF \\> 470 msec on 2 or more time points within a 24-hour period or family history of long QT syndrome.\n* Current use of a cytochrome P3A4 inhibitor or inducer and strong uridine diphosphate (UDP)-glucuronosyltransferase 1A1 (UGT1A1) inhibitors.'}, 'identificationModule': {'nctId': 'NCT04725994', 'briefTitle': 'Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idience Co., Ltd.'}, 'officialTitle': 'An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients with Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'ID-VDP-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'interventionNames': ['Drug: IDX-1197+XELOX']}, {'type': 'OTHER', 'label': 'Group 2', 'interventionNames': ['Drug: IDX-1197+Irinotecan']}], 'interventions': [{'name': 'IDX-1197+XELOX', 'type': 'DRUG', 'description': 'The dose levels will be escalated following a 3+3 dose escalation scheme.', 'armGroupLabels': ['Group 1']}, {'name': 'IDX-1197+Irinotecan', 'type': 'DRUG', 'description': 'The dose levels will be escalated following a 3+3 dose escalation scheme.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'USC Norris Comp. Cancer Ctr Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Hematology Oncology Clinic Baton Rouge / Sarah Cannon', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08816', 'city': 'East Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Astera Cancer Care', 'geoPoint': {'lat': 40.42788, 'lon': -74.41598}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'The Sixth Affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Shanghai East Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '49201', 'city': 'Busan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '02841', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Severance Hospital - Yonsei Cancer Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Won Sik Lee', 'role': 'CONTACT', 'email': 'wonsiklee@idience.com', 'phone': '8225263622'}, {'name': 'Minju Hong', 'role': 'CONTACT', 'email': 'minju.hong@idience.com', 'phone': '8225263644'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idience Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}