Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:23 AM
Study NCT ID:
NCT07481357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1', 'timeFrame': '21 days'}, {'measure': 'Optimal Biological Effective Dose (OBED) Based on best Overall Response Rate (ORR)', 'timeFrame': '42 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric (Stomach) Cancer', 'GastroEsophageal Cancer', 'Pancreatic Ductal Adenocarcinoma (mPDAC)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC/GEJ and advanced CLDN18.2+ PDAC.\n\nParticipants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged ≥ 19 years\n2. Histologically or cytologically documented advanced CLDN18.2+ GC/GEJ adenocarcinoma or advanced CLDN18.2+ PDAC\n3. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\n4. Life expectancy ≥12 weeks as judged by the Investigator\n\nExclusion Criteria:\n\n1. Cardiac abnormalities\n2. Gastrointestinal abnormalities\n3. Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV).\n4. Active systemic infection requiring IV antibiotics therapy.'}, 'identificationModule': {'nctId': 'NCT07481357', 'briefTitle': 'A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A First-In-Human Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'DA3501_AMST_I/IIa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1', 'description': 'Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks.', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 2', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 3', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 4', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 5', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 6', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 7', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 8', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 9', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 10', 'interventionNames': ['Drug: DA-3501']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 11', 'interventionNames': ['Drug: DA-3501']}], 'interventions': [{'name': 'DA-3501', 'type': 'DRUG', 'description': 'Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks.', 'armGroupLabels': ['Dose Level 1', 'Dose Level 10', 'Dose Level 11', 'Dose Level 2', 'Dose Level 3', 'Dose Level 4', 'Dose Level 5', 'Dose Level 6', 'Dose Level 7', 'Dose Level 8', 'Dose Level 9']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiwon Shin', 'role': 'CONTACT', 'email': 'jiwon_shin@donga.co.kr', 'phone': '82-2-920-8768'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}