Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT07216560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First-in-human Study of 7MW4911 in GI Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-10-10', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarker for efficacy', 'timeFrame': 'Up to approximately 2 years', 'description': 'To explore the relationship between the expression of CDH17 in tumor tissues and other biomarkers and the efficacy and safety of 7MW4911 in patients with advanced colorectal cancer and selected gastrointestinal tumor types'}], 'primaryOutcomes': [{'measure': 'Incidence and rates of adverse events', 'timeFrame': 'Up to approximately 2 years', 'description': 'To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors'}, {'measure': 'MTD, RED, and RP2D', 'timeFrame': 'Up to approximately 2 years', 'description': 'To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)'}], 'secondaryOutcomes': [{'measure': 'Tmax of 7MW4911', 'timeFrame': 'up to 3 months', 'description': 'time to maximum concentration of 7MW4911 in blood'}, {'measure': 'Cmax of 7MW4911', 'timeFrame': 'up to 3 months', 'description': 'maximum concentration of 7MW4911 in bloood'}, {'measure': 'Half life of 7MW4911', 'timeFrame': 'up to 3 months', 'description': 'time to decrease of 7MW4911 concentration by 50% in blood'}, {'measure': 'Area under the curve of 7MW4911', 'timeFrame': 'up to 3 months', 'description': 'Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)'}, {'measure': 'Objective response rate', 'timeFrame': 'Up to approximately 2 years', 'description': 'proportion of patients whose turmor response meet the criteria of complete response or partial response'}, {'measure': 'Progression-free survival', 'timeFrame': 'up to approximately 2 years', 'description': 'Duration in months from enrollment to first disease progression'}, {'measure': 'Immunogenicity of 7MW4911', 'timeFrame': 'Up to approximately 2 years', 'description': 'Incidence and rates of ADA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GI Cancers']}, 'descriptionModule': {'briefSummary': 'This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 and above\n2. ECOG 0-1\n3. Life expectancy ≥ 3 months\n4. Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.\n5. Disease progression after the most recent treatment regimen\n6. At least one measurable lesion according to RECIST v1.1\n7. Provision of archival tumor tissue or fresh biopsy.\n8. Adequte hematologic funciton, liver function and renal function.\n9. Comply with contraceptive requirements\n\nExclusion Criteria:\n\n1. Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.\n2. Active, untreated or symptomatic CNS metastasis\n3. Effusions that require frequent drainage\n4. Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.\n5. Severe respiratory disease that required hospitalization in the last 28 days.\n6. Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration\n7. Poorly controlled blood glucose with fasting blood glucose above 10mmol/L\n8. Recipient of allogeneic stem cell transplant or organ transplant\n9. Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.\n10. Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.\n11. Prohibited treatment and treatment that requires washout period\n\n 1. Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy.\n 2. Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration.\n 3. Major surgeries within 28 days prior to study drug administration\n 4. Investigational therapy within 28 days prior to study drug administration\n 5. Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed.\n 6. Use of strong CYP3A4 inhibitor or inducer\n12. Known hypersensitivity to 7MW4911 or components of the formulation\n13. Abuse of narcotic or psychoactive drugs\n14. Pregnant or breastfeeding women\n15. Other circumstances or conditions where the investigator judges to be unsuitable for study.'}, 'identificationModule': {'nctId': 'NCT07216560', 'briefTitle': 'First-in-human Study of 7MW4911 in GI Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mabwell (Shanghai) Bioscience Co., Ltd.'}, 'officialTitle': 'A Phase I/II Study of 7MW4911 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Advanced Colorectal Cancer and Other Advanced Gastrointestinal Tumors', 'orgStudyIdInfo': {'id': '7MW4911-CP101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7MW4911', 'interventionNames': ['Drug: 7MW4911']}], 'interventions': [{'name': '7MW4911', 'type': 'DRUG', 'description': 'study drug', 'armGroupLabels': ['7MW4911']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mabwell (Shanghai) Bioscience Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}