Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-27 @ 1:39 AM
Study NCT ID:
NCT05397093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2022-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ITIL-306 in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2039-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)', 'timeFrame': 'Up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 60 months', 'description': 'ORR defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by investigator review.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 60 months', 'description': 'For participants who experience an objective response, DOR is defined as the time from their first objective response to disease progression or death.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 60 months', 'description': 'PFS is defined as the time from the ITIL-306 infusion date to the date of disease progression or death from any cause.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 60 months', 'description': 'OS is defined as the time from the ITIL-306 infusion date to the date of death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ITIL-306', 'Cell Therapy', 'Epithelial ovarian cancer (EOC)', 'Non-small cell lung cancer (NSCLC)', 'Renal cell carcinoma (RCC)', 'Fallopian tube carcinoma', 'Tumor Infiltrating Lymphocytes', 'TIL', 'T-cell therapy', 'Folate receptor α (FOLR1)', 'Anti-folate receptor α (FOLR1)', 'Autologous Adoptive Cell Therapy', 'Checkpoint, PD-1 axis inhibitor', 'Peritoneal carcinoma', 'Cellular Immunotherapy', 'Immuno-oncology', 'Costimulatory antigen receptor (CoStAR)'], 'conditions': ['Epithelial Ovarian Cancer', 'Non-small Cell Lung Cancer', 'Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': "ITIL-306-201 is a phase 1a/1b, multicenter, clinical trial evaluating the safety and feasibility of ITIL-306 in adult participants with advanced solid tumors whose disease has progressed after standard therapy. ITIL-306 is a cell therapy derived from a participant's own tumor-infiltrating immune cells (lymphocytes; TILs) and contains a unique molecule designed to increase TIL activity when it encounters folate receptor α (FOLR1) on the tumor."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histologically documented advanced (metastatic and/or unresectable) disease as appropriate per cohort.\n\n * Phase 1a Dose Escalation: High-grade serous epithelial carcinoma of the ovary, fallopian tube, or peritoneum, adenocarcinoma of the lung, or clear-cell renal cell carcinoma.\n * Phase 1b Expansion:\n\n * Cohort 1: High grade serous, endometrioid, or clear cell epithelial carcinoma of the ovary, fallopian tube, or peritoneum.\n * Cohort 2: Squamous-cell carcinoma or adenocarcinoma of the lung.\n * Cohort 3: Clear cell or papillary RCC.\n* Disease must have unequivocally progressed during or after at least 1 prior line of systemic therapy that must include the following parameters (by indication):\n\n * Phase 1a dose escalation and Phase 1b Cohort 1: Participants with EOC whose disease has progressed during or after 1 prior line (at least 4 cycles) of platinum-based chemotherapy and had disease progression within 6 months from the last dose of the platinum agent. Participants who received 2 or more lines of platinum therapy must have disease which has progressed on or within 6 months after the date of the last dose of the platinum agent. Participants with BRCA-mutated EOC must have received previous PARP inhibitor therapy.\n * Phase 1a dose escalation and Phase 1b Cohort 2: Participants with NSCLC whose disease has progressed after 1 prior line of platinum-based doublet chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK/KRAS) are required to have progressed on targeted therapy in addition to a platinum-based doublet chemotherapy\n * Phase 1a dose escalation and Phase 1b Cohort 3: Participants with RCC whose disease has progressed after 1 prior line of antiangiogenic therapy and a PD-1-axis inhibitor.\n* Medically suitable for surgical resection of tumor tissue\n* Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate bone marrow and organ function\n\nKey Exclusion Criteria:\n\n* History of another primary malignancy within the previous 3 years\n* Phase 1a:\n\n * EOC of the following subtypes: low-grade, endometrioid, clear cell, mucinous, sarcomatous, or mixed.\n * NSCLC of the following subtypes: squamous, neuroendocrine differentiation.\n * RCC of the following subtypes: nonclear-cell RCC\n* Phase 1b:\n\n * Cohort 1: Participants with mucinous, sarcomatous, and low-grade EOC.\n * Cohort 2: Participants with small cell lung cancer, or NSCLC with neuroendocrine differentiation\n * Cohort 3: Participants with nonclear-cell RCC, except papillary RCC\n* Previously received an allogeneic stem cell transplant or organ allograft\n* Previously received TIL or engineered cell therapy (eg, CAR T-cell)\n* Significant cardiac disease\n* Stroke or transient ischemic attack within 12 months of enrollment\n* History of significant central nervous system (CNS) disorder\n* Symptomatic and/or untreated CNS metastases\n* History of significant autoimmune disease within 2 years prior to enrollment\n* Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO), human serum albumin (HAS), phosphate buffer or gentamycin'}, 'identificationModule': {'nctId': 'NCT05397093', 'briefTitle': 'ITIL-306 in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Instil Bio'}, 'officialTitle': 'A Phase 1a/1b, Open-Label, Multicenter Study Evaluating the Safety and Feasibility of ITIL-306 in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'ITIL-306-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1a: Dose Escalation', 'description': 'Various doses will be tested in participants with EOC, NSCLC and RCC.', 'interventionNames': ['Biological: ITIL-306']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Expansion', 'description': 'Cohort 1: Participants with epithelial ovarian cancer (EOC)\n\nCohort 2: Participants with non-small cell lung cancer (NSCLC)\n\nCohort 3: Participants with renal cell carcinoma (RCC)', 'interventionNames': ['Biological: ITIL-306']}], 'interventions': [{'name': 'ITIL-306', 'type': 'BIOLOGICAL', 'description': "ITIL-306 is a cell therapy product derived from a participant's own TILs and contains a unique molecule designed to increase TIL activity when it encounters FOLR1 on the tumor. A portion of the participant's tumor is surgically removed to make a personalized ITIL-306 product. Once ITIL-306 has been made, the participant is treated with 3 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by 2 days of rest then a single infusion of ITIL-306.", 'armGroupLabels': ['Phase 1a: Dose Escalation', 'Phase 1b: Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Instil Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instil Bio, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instil Bio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}