Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT06046495
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2023-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-02-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety profile of PLB1004 per CTCAE v5.0', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'To define the DLTs and MTD', 'timeFrame': 'Up to 3 years'}, {'measure': 'Area Under the Curve (AUC) of PLB1004', 'timeFrame': 'Approximately 28 days.'}, {'measure': 'Maximum plasma concentration (Cmax) of PLB1004', 'timeFrame': 'Approximately 28 days.'}, {'measure': 'Time to maximum plasma concentration (Tmax) of PLB1004', 'timeFrame': 'Approximately 28 days.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document;\n2. Male or female adult patients 18 years of age or older;\n3. Patients should have recovered from toxicities related to prior anti-tumor therapy;\n4. Patients should have recovered from the effects of major surgery;\n5. Have a documented EGFR mutation by a local test in tissue or plasma;\n6. At least 12 weeks life expectancy;\n7. Must have at least one measurable lesion per RECIST v 1.1;\n8. Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Received radiotherapy within 14 days before enrollment;\n2. Have significant or uncontrolled systemic disease;\n3. Have significant or uncontrolled cardiovascular disease;\n4. Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;\n5. Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;\n6. Have known hypersensitivity to the similar drugs and excipients of PLB1004;\n7. Pregnant or lactating women;\n8. Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;\n9. Have any condition or illness that could affect the compliance with the protocol.'}, 'identificationModule': {'nctId': 'NCT06046495', 'briefTitle': 'A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avistone Biotechnology Co., Ltd.'}, 'officialTitle': 'A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'PLB1004-I-US01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PLB1004', 'description': 'PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.', 'interventionNames': ['Drug: PLB1004']}], 'interventions': [{'name': 'PLB1004', 'type': 'DRUG', 'description': 'PLB1004 will be orally self-administered by the patient as a mono-therapy.', 'armGroupLabels': ['PLB1004']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817-1514', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director, MD', 'role': 'CONTACT'}], 'facility': 'University of California-Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director, MD', 'role': 'CONTACT'}], 'facility': 'Nebraska Cancer Specialists', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '100021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director, MD', 'role': 'CONTACT'}], 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director, MD', 'role': 'CONTACT'}], 'facility': 'Swedish Health Sciences', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Avistone Clinical Study Information Center Center', 'role': 'CONTACT', 'email': 'information.center@avistonebio.com', 'phone': '+86-10-84148921'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avistone Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}