Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 9:16 AM
Study NCT ID:
NCT07359820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-16', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.', 'timeFrame': 'Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1.', 'timeFrame': 'Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.'}, {'measure': 'Number of patients with adverse events and serious adverse events.', 'timeFrame': 'Every cycle (4-week cycles) until study discontinuation, approximately 24 months.'}, {'measure': 'Number of patients with dose interruptions.', 'timeFrame': 'Every 28-day cycle until end of treatment, approximately 24 months.'}, {'measure': 'Number of patients with dose reductions.', 'timeFrame': 'Every 28-day cycle until end of treatment, approximately 24 months.'}, {'measure': 'Number of patients with dose discontinuations.', 'timeFrame': 'Every 28-day cycle until end of treatment, approximately 24 months.'}, {'measure': 'Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1.', 'timeFrame': 'Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.'}, {'measure': 'Duration of Response (DOR) as assessed by Investigator per RECIST v1.1.', 'timeFrame': 'Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months'}, {'measure': 'Disease control rate (DCR) as assessed by Investigator and Independent Review Committee per RECIST v1.1.', 'timeFrame': 'Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.'}, {'measure': 'Progression-free survival (PFS) as assessed by Investigator and Independent Review Committee per RECIST v1.1.', 'timeFrame': 'Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months'}, {'measure': 'Overall survival (OS).', 'timeFrame': 'Up to approximately 36 months.'}, {'measure': 'Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.', 'timeFrame': 'Up to approximately 36 months.'}, {'measure': 'Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.', 'timeFrame': 'Up to approximately 36 months'}, {'measure': 'Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)', 'timeFrame': '[Time Frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)]'}, {'measure': 'Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)'}, {'measure': 'Pharmacokinetic parameters including half-life (t1/2)', 'timeFrame': 'Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)'}, {'measure': 'Change from baseline in quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).', 'timeFrame': 'Approximately every 4 weeks during treatment, approximately 24 months', 'description': 'It scores (0-100) where higher means better function/quality of life in that section of the questionnaire and higher means worse symptoms in that section of the questionnaire.'}, {'measure': 'Time to deterioration (TTD).', 'timeFrame': 'Up to approximately 36 months.'}, {'measure': 'FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.', 'timeFrame': 'Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months.'}, {'measure': 'Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23).', 'timeFrame': 'Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months.'}, {'measure': 'Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)', 'timeFrame': 'Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months'}, {'measure': 'Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)', 'timeFrame': 'Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months'}, {'measure': 'Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).', 'timeFrame': 'Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['FGFR2 Gene Fusion/Rearrangement', 'Other Solid Tumors, Adult']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement.\n\nParticipants will:\n\n* Take lirafugratinib regularly as instructed by their study doctor.\n* Visit the clinic as instructed for checkups and tests.\n* Keep a diary recording each time a dose of lirafugratinib is taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unresectable, locally advanced, or metastatic solid tumor (other than CCA).\n* Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor.\n* Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1.\n* Previously (\\>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies.\n* Subject has not received prior treatment with an FGFRi.\n\nExclusion Criteria:\n\n* An uncontrolled comorbidity.\n* Patient does not have adequate organ function (defined in protocol).\n* Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol).\n* QT interval corrected using Fridericia's formula (QTcF) \\> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome.\n* Clinically significant, uncontrolled cardiovascular disease.\n* CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms."}, 'identificationModule': {'nctId': 'NCT07359820', 'acronym': 'ReFocus202', 'briefTitle': 'A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elevar Therapeutics'}, 'officialTitle': 'A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement', 'orgStudyIdInfo': {'id': 'ELE-4008-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lirafugratinib', 'description': 'Treatment with standard dose of lirafugratinib', 'interventionNames': ['Drug: Lirafugratinib']}], 'interventions': [{'name': 'Lirafugratinib', 'type': 'DRUG', 'otherNames': ['RLY-4008'], 'description': 'Lirafugratinib is an oral inhibitor of FGFR2', 'armGroupLabels': ['Lirafugratinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '94805', 'city': 'Paris', 'country': 'France', 'facility': 'Gustave Roussy Cancer Campus', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08023', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'START Barcelona-Hospital HM Nou Delfos', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Jiménez Díaz- START MADRID', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario HM Sanchinarro-START MADRID-CIOCC', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'W1G 6AD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Sarah Cannon Research Institute UK', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Jacki Dillingham', 'role': 'CONTACT', 'email': 'jdillingham@elevartx.com', 'phone': '+1 (385) 276-3611'}, {'name': 'Lissa Nazal', 'role': 'CONTACT', 'email': 'lnazal@elevartx.com', 'phone': '+1 (385) 276-3621'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elevar Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}