Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT03973333
Status:
WITHDRAWN
Last Update Posted:
2024-10-18
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential from arm monotherapy IV dose escalation is opened first; then monotherapy SC dose escalation, monotherapy expansion and combination dose escalation may run'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study withdrawn by Sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-05-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Incidence of dose-limiting toxicities (DLT)', 'timeFrame': 'From first dose to DLT period (28 days)'}, {'measure': 'Phase 1: incidence and severity of adverse events (AE)', 'timeFrame': 'from first dose to 30 days after the last dose'}, {'measure': 'Phase 1: changes in laboratory parameters', 'timeFrame': 'from first dose to 30 days after the last dose', 'description': 'Abnormalities will be classified according to NCI CTCAE v5.0'}, {'measure': 'Phase 1: changes in vital signs', 'timeFrame': 'from first dose to 30 days after the last dose', 'description': 'Abnormalities will be classified according to NCI CTCAE v5.0'}, {'measure': 'Phase 1: changes in electrocardiogram parameters', 'timeFrame': 'from first dose to 30 days after the last dose', 'description': "QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval absolute values and changes from baseline will be summarized"}, {'measure': 'Phase 1: dose interruptions, reductions, and discontinuations', 'timeFrame': 'from first dose through last dose (anticipated for up to 12-24 months)'}, {'measure': 'Phase 2: Best overall response (BOR)', 'timeFrame': 'from first dose to approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Phase 2: incidence and severity of adverse events (AE)', 'timeFrame': 'from first dose to 30 days after the last dose'}, {'measure': 'Phase 2: changes in laboratory parameters', 'timeFrame': 'from first dose to 30 days after the last dose', 'description': 'Abnormalities will be classified according to NCI CTCAE v5.0'}, {'measure': 'Phase 2: changes in vital signs', 'timeFrame': 'from first dose to 30 days after the last dose', 'description': 'Abnormalities will be classified according to NCI CTCAE v5.0'}, {'measure': 'Phase 2: changes in electrocardiogram parameters', 'timeFrame': 'from first dose to 30 days after the last dose', 'description': 'QTcF interval absolute values and changes from baseline will be summarized'}, {'measure': 'Phase 2: dose interruptions, reductions, and discontinuations', 'timeFrame': 'from first dose through last dose (anticipated for up to 12-24 months)'}, {'measure': 'Phase 1: Best overall response', 'timeFrame': 'from first dose to approximately 2 years'}, {'measure': 'Progression-free survival', 'timeFrame': 'from first dose to approximately 2 years'}, {'measure': 'Duration of response', 'timeFrame': 'from first dose to approximately 2 years'}, {'measure': 'Overall survival', 'timeFrame': 'from first dose to approximately 2 years'}, {'measure': 'Pharmacokinetics Area under the plasma concentration-time curve (AUC)', 'timeFrame': 'from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)'}, {'measure': 'Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax)', 'timeFrame': 'from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)'}, {'measure': 'Pharmacokinetics The time to reach maximum plasma concentration (Tmax)', 'timeFrame': 'from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)'}, {'measure': 'Pharmacokinetics The elimination half-life (t1/2)', 'timeFrame': 'from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)'}, {'measure': 'Immunogenicity the incidence of anti-drug antibody formation', 'timeFrame': 'from first dose to 14 days after the last dose'}, {'measure': 'Changes in lymphocyte counts over time', 'timeFrame': 'from first dose to approx 4 weeks'}, {'measure': 'Changes in serum cytokines over time', 'timeFrame': 'from first dose to approx.. 4wks'}, {'measure': 'GCIG CA-125 response (ovarian carcinoma)', 'timeFrame': 'from first dose to approx.. 30 days after the last dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ImmTAC, IMC-C103C, MAGE-A4, immunotherapy'], 'conditions': ['Select Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'IMC-C103C is an immune mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.', 'detailedDescription': 'The IMC-C103C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases.\n\n1. To identify the maximum tolerated dose (MTD) and/or expansion dose of IMC-C103C as a single agent administered intravenously (IV) and subcutaneously (SC) once weekly (Q1W) and administered Q1W in combination with once every 3 weeks (Q3W) atezolizumab.\n2. To assess the preliminary anti-tumor activity of IMC-C103C in one or more selected indications, as a single agent administered Q1W.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HLA-A\\*02:01 positive\n2. MAGE-A4 positive tumor\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\[ECOG PS\\] 0 or 1\n4. Selected advanced solid tumors\n5. Relapsed from, refractory to, or intolerant of standard therapy\n6. Measurable disease per RECIST v1.1 (expansion)\n7. If applicable, must agree to use highly effective contraception\n\nExclusion Criteria:\n\n1. Symptomatic or untreated central nervous system metastasis\n2. Inadequate washout from prior anticancer therapy\n3. Significant ongoing toxicity from prior anticancer treatment\n4. Impaired baseline organ function as evaluated by out-of-range laboratory values\n5. Clinically significant cardiac disease\n6. Active infection requiring systemic antibiotic therapy\n7. Known history of human immunodeficiency virus (HIV)\n8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)\n9. Ongoing treatment with systemic steroids or other immunosuppressive therapies\n10. Significant secondary malignancy\n11. Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT03973333', 'briefTitle': 'Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunocore Ltd'}, 'officialTitle': 'A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as Single Agent and in Combination With Atezolizumab in HLA-A*0201-positive Patients With Advanced MAGE-A4-positive Cancer', 'orgStudyIdInfo': {'id': 'IMC-C103C-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMC-C103C - Monotherapy IV dose escalation', 'description': 'n= approximately 50 patients to establish the MTD/expansion dose', 'interventionNames': ['Drug: IMC-C103C']}, {'type': 'EXPERIMENTAL', 'label': 'IMC-C103C and atezolizumab dose escalation', 'description': 'n=approximately 12 patients to establish the MTD/expansion dose', 'interventionNames': ['Drug: IMC-C103C', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'IMC-C103C - expansion', 'description': 'Patients will be enrolled n=9-24 per expansion cohort (up to 4 total): metastatic/unresectable tumors of interest patients treated at the expansion dose of IMC-C103C to assess preliminary anti-tumor efficacy', 'interventionNames': ['Drug: IMC-C103C']}, {'type': 'EXPERIMENTAL', 'label': 'IMC-C103C monotherapy SC dose escalation', 'description': 'Patients will be enrolled n=9-12 to establish the MTD/expansion dose', 'interventionNames': ['Drug: IMC-C103C']}], 'interventions': [{'name': 'IMC-C103C', 'type': 'DRUG', 'description': 'Weekly IV infusions', 'armGroupLabels': ['IMC-C103C - Monotherapy IV dose escalation', 'IMC-C103C - expansion', 'IMC-C103C and atezolizumab dose escalation']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['TECENTRIQ'], 'description': 'IV infusions every 3 weeks', 'armGroupLabels': ['IMC-C103C and atezolizumab dose escalation']}, {'name': 'IMC-C103C', 'type': 'DRUG', 'description': 'Weekly subcutaneous Injection', 'armGroupLabels': ['IMC-C103C monotherapy SC dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic and Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Comprehenvise Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medicine & Biological Sciences', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute at Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28027', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica Universidad Navarra', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz - PPDS', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clinica Universidad Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': 'G12 OYN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'CH634JY', 'city': 'Bebington', 'country': 'United Kingdom', 'facility': 'The Clatterbridge Hospital Cancer Center', 'geoPoint': {'lat': 53.35, 'lon': -3.01667}}, {'zip': 'W1G 6AD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunocore Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}