Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04965220
Status:
UNKNOWN
Last Update Posted:
2023-08-09
First Post:
2021-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C560077', 'term': 'trametinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD', 'timeFrame': 'from first dose to the end of Cycle 1 (each cycle is 21 days)', 'description': 'maximum tolerated dose'}], 'secondaryOutcomes': [{'measure': 'RP2D', 'timeFrame': 'from first dose to the end of Cycle 1 (each cycle is 21 days)', 'description': 'Recommended dose for phase II clinical trials'}, {'measure': 'Peak Plasma Concentration (Cmax) of HLX208', 'timeFrame': 'from first dose to the beginning of Cycle 4 (each cycle is 21 days)', 'description': 'pharmacokinetics'}, {'measure': 'ORR', 'timeFrame': 'from first dose to the last patient was followed up for 6 month', 'description': 'The number of patients with CR or PR divided by the total number of treated patients whose disease was measurable at baseline'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)of HLX208', 'timeFrame': 'from first dose to the beginning of Cycle 4 (each cycle is 21 days)', 'description': 'pharmacokinetics'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18Y≤Age≤75Y\n* Good Organ Function\n* Expected survival time ≥ 3 months\n* Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment\n* Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.\n* ECOG score 0-1;\n* Expected survival time of more than 3 months;\n\nExclusion Criteria:\n\n* Previous treatment with BRAF inhibitors or MEK inhibitors\n* Symptomatic brain or meningeal metastases (unless the patient has been on \\> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).\n* Current or former patients with interstitial lung disease;\n* Active clinical severe infection;\n* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.\n* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.'}, 'identificationModule': {'nctId': 'NCT04965220', 'briefTitle': 'HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Henlius Biotech'}, 'officialTitle': 'A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'HLX208-MEK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ATC', 'description': 'HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)', 'interventionNames': ['Drug: HLX 208']}, {'type': 'EXPERIMENTAL', 'label': 'Primary brain tumor', 'description': 'HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)', 'interventionNames': ['Drug: HLX 208']}, {'type': 'EXPERIMENTAL', 'label': 'CRC(KRAS mutant)', 'description': 'HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)', 'interventionNames': ['Drug: HLX 208']}, {'type': 'EXPERIMENTAL', 'label': 'other solid tumor', 'description': 'HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)', 'interventionNames': ['Drug: HLX 208']}], 'interventions': [{'name': 'HLX 208', 'type': 'DRUG', 'otherNames': ['trametinib'], 'description': 'take orally', 'armGroupLabels': ['ATC', 'CRC(KRAS mutant)', 'Primary brain tumor', 'other solid tumor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Zhang', 'role': 'CONTACT', 'email': 'zhangli@sysucc.org.cn'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhang Li, leading PI', 'role': 'CONTACT', 'email': 'zhangli@sysucc.org.cn'}, {'name': 'Guo ye, PI', 'role': 'CONTACT', 'email': 'pattrickguo@gmail.com'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Henlius Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}