Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05451602
Status:
RECRUITING
Last Update Posted:
2022-10-27
First Post:
2022-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HEC169096 in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 456}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2022-07-03', 'studyFirstSubmitQcDate': '2022-07-06', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: MTD and RP2D of HEC169096', 'timeFrame': 'Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study', 'description': 'Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096'}, {'measure': 'Phase 2: Overall Response Rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.', 'detailedDescription': 'This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive NSCLC, MTC, and other tumors with RET activation. Phase I of this study includes a dose-escalation phase and a dose-expansion phase , which will focus on exploring MTD and/or RP2D of HEC169096 in patients with advanced solid tumours; Phase II will assess the efficacy and safety of HEC169096 at the RP2D dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.\n* Phase 2： All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor.\n* Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.\n* Measurable or non-measurable disease as determined by RECIST 1.1;\n* Adequate hematologic, hepatic and renal function;\n* Life expectancy of at least 12 weeks;\n* Negative pregnancy test (urine or serum) for female patients of childbearing potential;\n* Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy).\n\nExclusion Criteria:\n\n* Participant's cancer has a known primary driver alteration other than RET.\n* Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment;\n* Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment;\n* Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment);\n* Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment;\n* Had received live vaccine within 4 weeks prior to study treatment;\n* Had received any investigational agent from other clinical study within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment or are currently participating in other clinical trials;\n* Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment .\n* Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.\n* Patients with other malignant tumors within 5 years before the first use of drugs\n* Patients have a history of severe cardiovascular disease;\n* Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL or ≥ 10\\^4 cps/ mL; Hepatitis B: HCV antibody-positive and HCV-RNA positive), HIV antibody-positive.\n* Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment;\n* Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage);\n* Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption;\n* Patients have been treated with any strong CYP3A inhibitors or inducers within 2 weeks prior to the first dose or PPIs in the first week before the first dose."}, 'identificationModule': {'nctId': 'NCT05451602', 'briefTitle': 'HEC169096 in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Lake Pharma Co., Ltd.'}, 'officialTitle': 'Phase 1/2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'HEC169096-ST-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEC169096', 'description': 'Multiple doses of HEC169096', 'interventionNames': ['Drug: HEC169096']}], 'interventions': [{'name': 'HEC169096', 'type': 'DRUG', 'description': 'Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.', 'armGroupLabels': ['HEC169096']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiyan Tu', 'role': 'CONTACT', 'email': 'tuhaiyan@gdph.org.cn', 'phone': '13798012949'}], 'facility': 'GuangDong Province Peoples Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Lake Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}