Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05573035
Status:
TERMINATED
Last Update Posted:
2025-07-01
First Post:
2022-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate LYL845 in Adults With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm, open-label, dose-escalation and -expansion study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Pipeline Reprioritization', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicities (DLTs)', 'timeFrame': 'Up to 28 days', 'description': 'Evaluate incidence of dose-limiting toxicities (DLTs)'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate incidence of treatment-emergent adverse events (TEAEs)'}, {'measure': 'Severity of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate severity of treatment-emergent adverse events (TEAEs)'}, {'measure': 'Determine recommended Phase 2 Dose Range (RP2DR)', 'timeFrame': 'Up to 2 years', 'description': 'Determine the recommended Phase 2 dose range (during dose-escalation phase)'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR) by RECIST, version 1.1', 'timeFrame': 'up to 2 years', 'description': 'Evaluate anti-tumor activity of LYL845 based on overall response rate (ORR) by RECIST, version 1.1'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'up to 2 years', 'description': 'Evaluate duration of response (DOR)'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'Evaluate progression-free survival (PFS)'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 2 years', 'description': 'Evaluate overall survival (OS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TIL', 'tumor infiltrating lymphocyte', 'melanoma', 'non-small cell lung cancer', 'colorectal cancer', 'NSCLC', 'CRC', 'relapsed', 'refractory', 'locally advanced', 'advanced', 'metastatic', 'epigenetic'], 'conditions': ['Melanoma', 'Non-small Cell Lung Cancer', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).', 'detailedDescription': 'This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). During the dose-escalation phase of the study (Part A), participants with melanoma will be enrolled. Once a safe recommended Phase 2 dose range (RP2DR) has been established in Part A, enrollment will be expanded (Part B) to include additional participants with melanoma, NSCLC and CRC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years up to ≤ 75 years at the time of informed consent\n* Confirmed diagnosis of melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) that is metastatic or locally advanced or unresectable and is relapsed and/or refractory (R/R) after standard therapy for each tumor histology\n* Participants must have received prior systemic treatment for their metastatic disease or locally advanced disease based on tumor type as follows:\n* Melanoma: participants with disease progression following an immune checkpoint inhibitor (CPI)\n* NSCLC: participants with disease progression following at least 1 approved systemic therapy, including an immune CPI-containing regimen for appropriate patients or an approved targeted therapy for known molecular abnormalities if applicable to their disease\n* CRC: participants with disease progression following at least 1 line of therapy, including a fluoropyrimidine with oxaliplatin or irinotecan. Microsatellite instability (MSI) high/mismatch repair deficient (dMMR) CRC participants must have disease progression following systemic therapy with immune CPIs.\n* Measurable disease including at least 1 lesion that is safely resectable AND a target lesion to measure response and an additional lesion for biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ and marrow function\n* Women of childbearing potential must have a negative pregnancy test at screening\n* All participants must agree to practice highly effective methods of contraception\n* Fully recovered from toxicity from prior systemic anticancer therapy\n\nExclusion Criteria:\n\n* Prior treatment with adoptive cellular therapy\n* Prior solid organ transplantation\n* Central nervous system (CNS) involvement of disease that is extensive, symptomatic or untreated, or patients with leptomeningeal disease\n* Uncontrolled or symptomatic pleural effusion or ascites\n* Untreated or active systemic infection\n* Active autoimmune disease requiring treatment or primary immunodeficiency syndrome\n* Systemic corticosteroids at a dose of \\>10 mg of prednisone or equivalent per day\n* Other primary malignancy within 3 years prior to enrollment\n* Impaired cardiac function or clinically significant cardiovascular disease\n* Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors\n* Pregnant or nursing (lactating) women'}, 'identificationModule': {'nctId': 'NCT05573035', 'briefTitle': 'A Study to Investigate LYL845 in Adults With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lyell Immunopharma, Inc.'}, 'officialTitle': 'A Phase 1 Study to Assess the Safety and Efficacy of LYL845 in Adults With Relapsed and/or Refractory Metastatic or Locally Advanced Melanoma and Selected Solid Tumor Malignancies', 'orgStudyIdInfo': {'id': 'LYL845-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental LYL845', 'description': 'Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy', 'interventionNames': ['Biological: LYL845']}], 'interventions': [{'name': 'LYL845', 'type': 'BIOLOGICAL', 'description': 'LYL845 is an autologous tumor infiltrating lymphocyte (TIL) enhanced via Epi-R, a proprietary epigenetic reprogramming technology', 'armGroupLabels': ['Experimental LYL845']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Coomprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center, Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Comprehensive Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack Meridian Health Inc', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute at University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lyell Immunopharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}