Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT05025358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2021-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LP-118 in Patients With Advanced Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2021-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'Up to 24 months', 'description': 'The highest dose that does not cause unacceptable side effects or overt toxicities which will be assessed by NCI CTCAE v5.0.'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 24 months', 'description': 'The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.'}, {'measure': 'Recommended phase II dose (RP2D)', 'timeFrame': 'Up to 24 months', 'description': 'The safe dose that demonstrates the greatest pharmacological activity.'}, {'measure': 'PK evaluation of area under the plasma concentration versus time curve (AUC) of LP-118', 'timeFrame': 'Up to Cycle 6 (each cycle is 28 days)', 'description': 'AUC indicates the extent of exposure to LP-118 and its clearance rate from the body.'}, {'measure': 'PK evaluation of peak plasma concentration (Cmax) of LP-118', 'timeFrame': 'Up to Cycle 6 (each cycle is 28 days)', 'description': 'Cmax indicates the highest drug concentration in the blood after LP-118 administration.'}, {'measure': 'PK evaluation of time to maximum concentration (Tmax) of LP-118', 'timeFrame': 'Up to Cycle 6 (each cycle is 28 days)', 'description': 'Tmax indicates the time taken to reach the maximum drug concentration (i.e. Cmax).'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 24 months', 'description': 'The proportion of patients who have a partial or complete response after LP-118 treatment.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 24 months', 'description': 'The time from first documented response to disease progression or death.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 24 months', 'description': 'The time from first dose to disease progression or death, whichever occurs first.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 24 months', 'description': 'The time from first dose to the date of death from any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor', 'Lymphoma, Non-Hodgkin']}, 'descriptionModule': {'briefSummary': 'This is a phase I, multi-center, open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-118 in patients with advanced malignancies, including solid tumors and lymphomas. LP-118 is a BCL-2/BCL-XL small molecule inhibitor.', 'detailedDescription': 'LP-118 is an oral selective BCL-2 inhibitor with tuned BCL-XL activity, aiming to improve antitumor efficacy and reduce the risk of thrombocytopenia. Clinical development of LP-118 includes targeting of relapsed or refractory hematological malignancies and solid tumors. This is a multi-center, open-label, Phase 1 dose escalation study of LP-118 in patients with advanced malignancies, including advanced/metastatic solid tumors and relapsed/refractory B cell, T/NK cell lymphomas, to determine the safety, tolerability, pharmacokinetics profile and preliminary anti-tumor efficacy. Upon completion of the Phase 1 dose escalation study and establishment of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), the dose expansion study will be implemented in patients with protocol designated type of disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with histologically or cytologically confirmed malignancy, including either of the following disease: relapsed or refractory lymphomas with at least one measurable disease based on Lugano 2014 criteria; or advanced or metastatic solid tumors based on RECIST V1.1 criteria.\n* Subjects have a life expectancy of ≥12 weeks, and Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1.\n* Subjects must have adequate bone marrow function independent of blood transfusion or growth factor support per local laboratory reference range at Screening.\n* Subjects must have adequate coagulation, renal, and hepatic function, per local laboratory reference range at Screening.\n* All acute toxicity from previous anti-tumor treatment or surgery has been alleviated to NCI CTCAE 5.0 ≤ Grade 1.\n* All enrolled subjects should take medically approved contraceptives during the entire treatment period and within 90 days after the end of treatment.\n* Volunteer and sign informed consent, willing to follow trial protocol.\n\nExclusion Criteria:\n\n* Subjects who have undergone allogeneic or autologous hematopoietic stem cell transplantation or CAR-T cell therapy (except for lymphoma patients who had received autologous stem cell transplantation or CAR-T cell therapy before 90 days of the first dose of LP-118).\n* Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of study drug:\n\n * Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy;\n * Any investigational treatment;\n * Patients who have undergone major surgery, severe trauma or radiotherapy.\n* Subjects who have received the following treatments within 1 week before the first dose of study drug:\n\n * Steroids or traditional herbal medicine for antitumor purposes;\n * Strong and moderate CYP3A inhibitors and inducers, grapefruit and grapefruit juice;\n * Any medications that can cause QTc interval prolongation or torsional tachycardia.\n* Solid tumor patients with ITP or AIHA.\n* Subjects with known bleeding disease or with a history of non-chemotherapy induced thrombocytopenic bleeding or ineffective platelet transfusion within 1 year before the first dose of study drug.\n* Subjects with uncontrollable or CTCAE ≥ grade 2 gastrointestinal bleeding occurred within 90 days before the first dose of study drug.\n* Subjects have received the therapeutic dose of anticoagulant or antiplatelet drugs within 1 week before the first dose of study drug.\n* Subjects have any serious and/or uncontrolled systemic disease.\n* Subjects have poor cardiovascular function, in line with New York Heart Association (NYHA) cardiac function classification ≥ 2 or QTcF greater than 450ms (male) or 470ms (female) on ≥ 3 independent ECG.\n* Subjects have disease states where clinical manifestations may be difficult to control, including but not limited to HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.\n* Lymphoma with primary central nervous system (CNS) malignancy or any disease affects the CNS.\n* Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.\n* Subjects who have known severe allergies to study drugs or any excipients.\n* Subjects who have evidence of a second primary tumor.'}, 'identificationModule': {'nctId': 'NCT05025358', 'briefTitle': 'A Study of LP-118 in Patients With Advanced Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou Lupeng Pharmaceutical Company LTD.'}, 'officialTitle': 'A Phase I Study on Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of LP-118 in Patients With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'LP-118-CN101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LP-118', 'description': 'The classic "3+3" design at dose levels of 50mg, 100mg, 200mg, 300mg, 400mg and 500mg will be implemented in this study.', 'interventionNames': ['Drug: LP-118 tablet']}], 'interventions': [{'name': 'LP-118 tablet', 'type': 'DRUG', 'otherNames': ['NWP-4-76'], 'description': 'Subjects will administered orally with LP-118 tablet at the designated dose once daily, using approximately 240 mL of water during a meal or within 30 minutes after a meal, 28 days per cycle. The treatment will continue until progressive disease, unacceptable toxicity, etc.', 'armGroupLabels': ['LP-118']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510632', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'First Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yilong Wu, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Lupeng Pharmaceutical Company LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}