Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT05187858
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-24', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in pERK levels', 'timeFrame': 'Baseline and Cycle 1 (each cycle is 28 days) Day 14', 'description': 'Change from baseline in pERK levels will be evaluated'}, {'measure': 'Objective response rate (ORR) and disease control rate (DCR)', 'timeFrame': 'up to 2 years', 'description': 'Objective response rate (ORR) and disease control rate (DCR) will be determined using response evaluation criteria in solid tumors (RECIST) v1.1.'}], 'primaryOutcomes': [{'measure': 'Number of subjects with dose limiting toxicities (DLTs) at each dose level during the first cycle', 'timeFrame': 'up to Day 28', 'description': 'Dose limiting toxicities will be evaluated through the first cycle (each cycle is 28 days)'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with DLTs during the entire on-treatment period', 'timeFrame': 'up to 2 years', 'description': 'Dose limiting toxicities will be evaluated through the entire on-treatment period'}, {'measure': 'Number of subjects with Grade ≥3 treatment-related adverse events (AEs)', 'timeFrame': 'up to 2 years', 'description': 'Grade ≥3 treatment-related adverse events will be evaluated through the entire on-treatment period'}, {'measure': 'Number of subjects with treatment-related AEs at each dose level', 'timeFrame': 'up to 2 years', 'description': 'Treatment-related AEs at each dose level will be evaluated through the entire on-treatment period'}, {'measure': 'Maximum Plasma Concentration (Cmax) of LNP3794', 'timeFrame': 'Cycle 1 (each cycle is 28 days) Day 1 and Day 14', 'description': 'Cmax is the maximum observed plasma concentration.'}, {'measure': 'Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last])', 'timeFrame': 'Cycle 1 (each cycle is 28 days) Day 1 and Day 14', 'description': 'AUC\\[0-last\\] is the measure of plasma drug concentration from time zero to the time of last quantifiable concentration.'}, {'measure': 'Area under the concentration-time curve from time zero to the end of dosing interval (AUC[0-tau])', 'timeFrame': 'Cycle 1 (each cycle is 28 days) Day 1 to 2 and Day 14 to 15', 'description': 'AUC\\[0-tau\\] is the measure of plasma drug concentration from time zero to the end of dosing interval.'}, {'measure': 'Time to maximum concentration (Tmax)', 'timeFrame': 'Cycle 1 (each cycle is 28 days) Day 1 and Day 14', 'description': 'Tmax is the time to reach maximum plasma concentration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open-label, dose escalation study of LNP3794 (BI3011441) in subjects with NRAS/KRAS mutated advanced or metastatic refractory solid tumors. The purpose of this study is to evaluate the safety/tolerability, pharmacokinetic and pharmacodynamic profile of the orally administered LNP3794 (BI3011441) as monotherapy at selected dose levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects ≥18 years of age\n2. Pathologically documented, locally-advanced or metastatic solid malignancy with NRAS or KRAS mutation\n3. At least one target lesion that can be measured per RECIST version 1.1\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Adequate organ function (bone marrow, hepatic, renal, cardiovascular)\n6. Documented disease progression despite appropriate prior standard therapies or subjects for whom no standard therapy exists for their tumor type and disease stage\n7. Reproductive criteria (as defined in the protocol)\n\nExclusion Criteria:\n\n1. Subjects with symptomatic central nervous system (CNS) metastases\n2. History of another primary malignancy, with the exception of locally excised nonmelanoma skin cancer and carcinoma in situ of uterine cervix\n3. Known active hepatitis B infection or hepatitis C infection\n4. Known pre-existing interstitial lung disease\n5. Known diagnosis of human immunodeficiency virus (HIV) infection\n6. History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy; or known risk factors for RVO or central serous retinopathy\n7. Any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator, Sponsor, or contract research organization, could affect the subject's participation in the study\n8. Impaired cardiac function or clinically significant cardiac diseases\n9. Previous treatment with RAS or MEK targeting agents\n10. Chemotherapy, biologic therapy, immunotherapy, radiotherapy, or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study treatment"}, 'identificationModule': {'nctId': 'NCT05187858', 'briefTitle': 'A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lupin Ltd.'}, 'officialTitle': 'A Phase I Open-Label Study of LNP3794 (BI3011441) in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors', 'orgStudyIdInfo': {'id': 'LRP/LNP3794/2020/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LNP3794', 'description': 'Participants will receive LNP3794 orally once daily at different doses in 28 day cycles on a continuous basis', 'interventionNames': ['Drug: LNP3794']}], 'interventions': [{'name': 'LNP3794', 'type': 'DRUG', 'description': 'LNP3794 capsules administered orally once daily', 'armGroupLabels': ['LNP3794']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200 Bruxelles', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'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', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Dhanajay Bakhle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lupin Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lupin Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}