Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT04262466
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2020-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'C000719808', 'term': 'tebentafusp'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 727}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Incidence of dose-limiting toxicity (DLT)s', 'timeFrame': 'Up to ~28 days after each dose'}, {'measure': 'Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)', 'timeFrame': 'Up to 30 days after the last dose of study therapy'}, {'measure': 'Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations', 'timeFrame': 'Up to ~12 months'}, {'measure': 'Phase 1: Number of participants with abnormal laboratory test results (hematology)', 'timeFrame': 'Up to 30 days after the last dose of study therapy'}, {'measure': 'Phase 1: Number of participants with abnormal laboratory test results (chemistry)', 'timeFrame': 'Up to 30 days after the last dose of study therapy'}, {'measure': 'Phase 1: Number of participants with abnormal laboratory test results (coagulation)', 'timeFrame': 'Up to 30 days after the last dose of study therapy'}, {'measure': 'Phase 1: Number of participants with abnormal urinalysis', 'timeFrame': 'Up to 30 days after the last dose of study therapy'}, {'measure': 'Phase 1: Number of participants with abnormal vital signs', 'timeFrame': 'Up to 30 days after the last dose of study therapy'}, {'measure': 'Phase 1: Mean change from baseline in QTcF interval', 'timeFrame': 'Up to 30 days after the last dose of study therapy'}, {'measure': 'Phase 2: Best overall response (BOR)', 'timeFrame': 'Up to ~2 years'}], 'secondaryOutcomes': [{'measure': 'Phase I: Best Overall Response (BOR)', 'timeFrame': 'Up to ~2 years'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to ~2 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to ~2 years'}, {'measure': 'Overall survival', 'timeFrame': 'Up to ~2 years'}, {'measure': 'Area under the plasma concentration-time curve (AUC) of brenetafusp', 'timeFrame': 'At designated time points up to ~3 weeks'}, {'measure': 'Maximum plasma drug concentration (Cmax) of brenetafusp', 'timeFrame': 'At designated time points up to ~3 weeks'}, {'measure': 'Time to reach maximum plasma concentration (Tmax) of brenetafusp', 'timeFrame': 'At designated time points up to ~3 weeks'}, {'measure': 'Plasma elimination half-life (t½) of brenetafusp', 'timeFrame': 'At designated time points up to ~3 weeks'}, {'measure': 'Incidence of anti-brenetafusp antibody formation', 'timeFrame': 'Up to ~ 2 years'}, {'measure': 'Changes in lymphocyte counts over time', 'timeFrame': 'Up to ~3 weeks'}, {'measure': 'Changes in serum cytokines over time', 'timeFrame': 'Up to ~3 weeks'}, {'measure': 'Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria', 'timeFrame': 'Up to ~2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Select Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of brenetafusp in adult participants who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.', 'detailedDescription': 'The IMC-F106C-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. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of brenetafusp as a single agent and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies.\n2. Phase 2: To assess the efficacy of brenetafusp in selected advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ECOG PS 0 or 1\n2. HLA-A\\*02:01 positive\n3. PRAME positive tumor\n4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies\n5. If applicable, must agree to use highly effective contraception\n\nExclusion Criteria:\n\n1. Symptomatic or untreated central nervous system metastasis\n2. Recent bowel obstruction\n3. Ongoing ascites or effusion requiring recent drainages\n4. Significant immune-mediated adverse event with prior immunotherapy (Participants in checkpoint inhibitor combination treatment)\n5. Inadequate washout from prior anticancer therapy\n6. Significant ongoing toxicity from prior anticancer treatment\n7. Out-of-range laboratory values\n8. Clinically significant lung, heart, or autoimmune disease\n9. Ongoing requirement for immunosuppressive treatment\n10. Prior solid organ or bone marrow transplant\n11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection\n12. Significant secondary malignancy\n13. Hypersensitivity to study drug or excipients\n14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention\n15. Pregnant or lactating participants\n16. Any other contraindication for applicable combination partner based on local prescribing information'}, 'identificationModule': {'nctId': 'NCT04262466', 'briefTitle': 'Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunocore Ltd'}, 'officialTitle': 'Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers', 'orgStudyIdInfo': {'id': 'IMC-F106C-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brenetafusp Monotherapy', 'description': 'Participants receive brenetafusp.', 'interventionNames': ['Drug: Brenetafusp']}, {'type': 'EXPERIMENTAL', 'label': 'Brenetafusp and Anti-PD(L)1 Agent', 'description': 'Participants receive brenetafusp and pembrolizumab.', 'interventionNames': ['Drug: Brenetafusp and pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Brenetafusp and Chemotherapy', 'description': 'Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.', 'interventionNames': ['Drug: Brenetafusp and chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Brenetafusp and Targeted Therapy', 'description': 'Participants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.', 'interventionNames': ['Drug: Brenetafusp and tebentafusp', 'Drug: Brenetafusp and bevacizumab', 'Drug: Brenetafusp and kinase inhibitors']}, {'type': 'EXPERIMENTAL', 'label': 'Brenetafusp and Multimodal Therapy', 'description': 'Participants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.', 'interventionNames': ['Drug: Brenetafusp and monoclonal antibodies and chemotherapy']}], 'interventions': [{'name': 'Brenetafusp', 'type': 'DRUG', 'description': 'Brenetafusp IV infusions', 'armGroupLabels': ['Brenetafusp Monotherapy']}, {'name': 'Brenetafusp and pembrolizumab', 'type': 'DRUG', 'description': 'Brenetafusp and pembrolizumab IV infusions', 'armGroupLabels': ['Brenetafusp and Anti-PD(L)1 Agent']}, {'name': 'Brenetafusp and chemotherapy', 'type': 'DRUG', 'description': 'Brenetafusp and chemotherapy IV infusions', 'armGroupLabels': ['Brenetafusp and Chemotherapy']}, {'name': 'Brenetafusp and monoclonal antibodies and chemotherapy', 'type': 'DRUG', 'description': 'Brenetafusp and a monoclonal antibody therapy and chemotherapy', 'armGroupLabels': ['Brenetafusp and Multimodal Therapy']}, {'name': 'Brenetafusp and tebentafusp', 'type': 'DRUG', 'description': 'Brenetafusp and tebentafusp IV infusions', 'armGroupLabels': ['Brenetafusp and Targeted Therapy']}, {'name': 'Brenetafusp and bevacizumab', 'type': 'DRUG', 'description': 'Brenetafusp and bevacizumab IV infusions', 'armGroupLabels': ['Brenetafusp and Targeted Therapy']}, {'name': 'Brenetafusp and kinase inhibitors', 'type': 'DRUG', 'description': 'Brenetafusp and oral kinase inhibitors', 'armGroupLabels': ['Brenetafusp and Targeted Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California - San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Angeles Clinic and Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California Davis Comprehensive Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Houston Lee Moffitt Cancer Center & Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Oklahoma Peggy and Charles Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '92697', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Utah - Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Washington - Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'status': 'COMPLETED', 'country': 'Australia', 'facility': 'Scientia Clinical Research', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2065', 'city': 'Wollstonecraft', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Melanoma Institute Australia (MIA) - The Poche Centre', 'geoPoint': {'lat': -33.8328, 'lon': 151.18981}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '5020', 'city': 'Salzburg', 'status': 'COMPLETED', 'country': 'Austria', 'facility': 'LKH - Universitätsklinikum der PMU Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '4000', 'city': 'Liège', 'state': 'Luik', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'CHU de Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '1070', 'city': 'Brussels', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'UZA', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '91350-200', 'city': 'Porto Alegre', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Nossa Senhora da Conceicao', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Rio de Janeiro', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': "D'Or Institute for Research and Education", 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'COMPLETED', 'country': 'Canada', 'facility': 'CHUM Centre de Recherche', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Bordeaux', 'state': 'Gironde', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Bergonie - Nouvelle-Aquitaine', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '94805', 'city': 'Villejuif', 'state': 'Val De Marne', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Gustave Roussy (Institut de Cancerologie Gustave-Roussy)', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '69100', 'city': 'Lyon', 'state': 'Villeurbanne', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Universite Claude Bernard Lyon Est', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': "Hopital Saint-Louis - Centre d'Onco-Dermatologie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Universitaetsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Dublin', 'status': 'COMPLETED', 'country': 'Ireland', 'facility': 'St Vincents University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '00168', 'city': 'Rome', 'state': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS - 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