Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT03973151
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2017-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of HL-085 in NRAS Mutant Advanced Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-29', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2019-06-01', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Duration of the study, estimated to be approximately 24 months.', 'description': 'Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 during the study period'}, {'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'DLTs within the first cycle of therapy (up to 35 days)', 'description': 'The dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity (DLT)'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) as measure of efficacy', 'timeFrame': 'Duration of the study, estimated to be approximately 24 months.', 'description': 'Efficacy estimated as the Objective Response Rate (ORR) , which is the sum of Partial Response (PR) and Complete Response (CR) as determined by RECIST 1.1'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Duration of the study, estimated to be approximately 24 months', 'description': 'AUC of HL-085 following single and repeated dosing'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'Duration of the study, estimated to be approximately 24 months', 'description': 'Cmax of HL-085 following single and repeated dosing'}, {'measure': 'Time to maximum observed plasma drug concentration (Tmax)', 'timeFrame': 'Duration of the study, estimated to be approximately 24 months.', 'description': 'Tmax of HL-085 following single and repeated dosing'}, {'measure': 'Half-life (T1/2)', 'timeFrame': 'Duration of the study, estimated to be approximately 24 months.', 'description': 'T1/2 of HL-085 following single and repeated dosing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'NRAS'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '36600247', 'type': 'DERIVED', 'citation': 'Wang X, Luo Z, Chen J, Chen Y, Ji D, Fan L, Chen L, Zhao Q, Hu P, Sun P, Jia Z, Guo J, Si L. First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations. BMC Med. 2023 Jan 4;21(1):2. doi: 10.1186/s12916-022-02669-7.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma according to AJCC (Version 7, 2010).\n2. Subjects must have NRAS mutation in melanoma.\n3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.\n4. ECOG performance status of 0-1.\n5. Life expectancy ≥ 3 months.\n6. Ability to take the medicine orally.\n7. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Prior therapy with a MEK-inhibitor\n2. Patients with known hypersensitivity to study drug ingredients or their analogues.\n3. Active central nervous system (CNS) lesion.\n4. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.\n5. Subjects with bleeding symptoms at Grade 3 (NCI-CTCAE v4.03) within 4 weeks prior to starting study treatment.\n6. Uncontrolled concomitant diseases or infectious diseases.\n7. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).\n8. History of HIV,HCV,HBV infection.\n9. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.\n10. Serum HCG test is positive.\n11. Other conditions that influence the results and increase the risk of study.'}, 'identificationModule': {'nctId': 'NCT03973151', 'briefTitle': 'Study of HL-085 in NRAS Mutant Advanced Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Kechow Pharma, Inc.'}, 'officialTitle': 'A Phase I/II, Single Arm, Dose Escalation and Cohort Expansion Study to Evaluate Safety, Preliminary Efficacy of HL-085 in Patients With NRAS Mutant Advanced Melanoma', 'orgStudyIdInfo': {'id': 'HL-085-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HL-085', 'description': 'HL-085 will be administered as BID with specified dose.', 'interventionNames': ['Drug: HL-085']}], 'interventions': [{'name': 'HL-085', 'type': 'DRUG', 'description': 'HL-085 is one MEK inhibitor.', 'armGroupLabels': ['HL-085']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Hongqi Tian, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Kechow Pharma, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Kechow Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}